German language adaptation of the Cogniphobia Scale for Headache Disorders (CS-HD) and development of a new short form (CS-HD-6).

OBJECTIVE: This study is part of the ODIN-migraine (Optimization of Diagnostic Instruments in migraine) project. It is a secondary, a priori analysis of previously collected data, and aimed to assess the psychometric properties and factor structure of the Cogniphobia Scale for Headache Disorders (CS-HD). We aimed to construct a German-language version and a short version. BACKGROUND: Cogniphobia is the fear and avoidance of cognitive exertion, which the patient believes triggers or exacerbates headache. High cogniphobia may worsen the course of a headache disorder. METHODS: The 15-item CS-HD was translated into German and back translated in a masked form by a professional translator. Modifications were discussed and carried out in an expert panel. A cross-sectional online survey including the CS-HD and further self-report questionnaires was conducted in a sample of N = 387 persons with migraine (364/387 [94.1%] female, M = 41.0 [SD = 13.0] years, migraine without aura: 152/387 [39.3%], migraine with aura: 85/387 [22.0%], and chronic migraine: 150/387 [38.8%]). RESULTS: Exploratory factor analysis resulted in two clearly interpretable factors (interictal and ictal cogniphobia). Confirmatory factor analysis yielded an acceptable to good model fit (χ2(89) = 117.87, p = 0.022, χ2/df = 1.32, RMSEA = 0.029, SRMR = 0.055, CFI = 0.996, TLI = 0.995). Item response theory-based analysis resulted in the selection of six items for the short form (CS-HD-6). Reliability was acceptable to excellent (interictal cogniphobia subscale: ω = 0.92 [CS-HD] or ω = 0.77 [CS-HD-6]; ictal cogniphobia subscale: ω = 0.77 [CS-HD] or ω = 0.73 [CS-HD-6]). The pattern of correlations with established questionnaires confirmed convergent validity of both the CS-HD and the CS-HD-6. CONCLUSION: Both the CS-HD and the CS-HD-6 have good psychometric properties and are suitable for the assessment of cogniphobia in migraine.

Behavioral treatment for migraine prophylaxis in adults: Moderator analysis of a randomized controlled trial.

BACKGROUND: While growing evidence suggests the efficacy of various behavioral approaches to the preventive treatment of migraine, it remains largely unclear which behavioral interventions are indicated for which type of patient. This exploratory study aimed to identify moderators for the outcome between migraine-specific cognitive-behavioral therapy and relaxation training. METHODS: In this secondary analysis of an open-label randomized controlled trial, the data of N = 77 adults (completer sample) with migraine (mean age = 47.4, SD = 12.2, 88% female), who were allocated to either migraine-specific cognitive-behavioral therapy or relaxation training, was examined. Outcome was the frequency of headache days at the 12-month follow-up. We analyzed baseline demographic or clinical characteristics and headache-specific variables (disability, emotional distress, trigger sensitivity and avoidance, pain acceptance, self-efficacy) as candidate moderators. RESULTS: Higher headache-related disability (assessed via the Headache Impact Test, HIT-6, B = -0.41 [95% CI: -0.85 to -0.10], p = .047), higher anxiety (assessed via the subscale Anxiety of the Depression, Anxiety and Stress scales, DASS-A, B = -0.66 [95% CI: -1.27 to -0.02], p = .056), and the presence of a comorbid mental disorder (B = -4.98, [95% CI: -9.42 to -0.29], p = .053), moderated the outcome in favor of migraine-specific cognitive-behavioral therapy. CONCLUSION: Our findings contribute to an individualized treatment selection and suggest that preference for complex behavioral treatment (migraine-specific cognitive-behavioral therapy) should be given to patients with high headache-related disability, increased anxiety, or a comorbid mental disorder.Study Registration: Original study registered in the German Clinical Trials Register (https://drks.de/search/de; DRKS-ID: DRKS00011111).

What do patients' efficacy and tolerability ratings of acute migraine medication tell us? Cross-sectional data from the DMKG Headache Registry.

BACKGROUND: Most migraine patients need an effective acute medication. Real-world data can provide important information on the performance of acute migraine medication in clinical practice. METHODS: We used data from the German Migraine and Headache Society Headache Registry, where patients rate efficacy and tolerability of and satisfaction with each of their acute headache medications. RESULTS: A total of 1756 adult migraine patients (females: 85%, age: 39.5 ± 12.8 years, headache days per month: 13.5 ± 8.1) were included. Of these, 93% used acute medication, most frequently triptans (59.3%) and/or non-opioid analgesics (56.4%), and 58.5% rated efficacy as good or very good. This was more frequent for triptans (75.4%) than for non-opioid analgesics (43.6%, p < 0.001). Among non-opioid analgesics, naproxen was rated most effective (61.9% very good or good, p < 0.001 compared to ibuprofen, acetylsalicylic acid and paracetamol). Patient-rated efficacy significantly declined with higher headache frequencies (p < 0.001), and this effect remained significant after omitting patients overusing acute medication. CONCLUSION: In the present population recruited at specialized headache centers, patients rated triptans as more effective than non-opioid analgesics, naproxen as more effective than ibuprofen, and acute medication efficacy decreased with increasing headache frequency.Trial registration: The German Migraine and Headache Society Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

[Complementary and supplementary procedures in the treatment of headache]. / Komplementäre und ergänzende Verfahren in der Kopfschmerztherapie.

In Germany, headache is one of the illnesses that most frequently leads to health impairments and to consultation with physicians. Even in children, headache is often associated with restricted activities of daily life. Nevertheless, the level of care for headache disorders is disproportionate to the medical needs. As a result, patients regularly use complementary and supportive therapeutic procedures. This review shows the procedures currently used for primary headache in childhood and adulthood, the methodological approaches and existing scientific evidence. The safety of the therapeutic options is also classified. These methods include physiotherapy, neural therapy, acupuncture, homeopathy, phytotherapy and the intake of dietary supplements. For children and adolescents with headaches, there are studies in the field of dietary supplements for coenzyme Q10, riboflavin, magnesium and vitamin D, which indicate specific effects in the reduction of headaches.

[Fear of migraine attacks: diagnosis and treatment]. / Attackenangst bei Migräne: Diagnostik und Behandlung.

In the field of headache disorders, the term "fear of attacks" refers to the fear of a headache attack occurring. Excessive fear of attacks may worsen the course of a migraine and lead to an increase in migraine activity. In the assessment of attack-related fear, a categorical (fear of attacks as a specific phobia) and a dimensional approach (measuring the extent of fear using a questionnaire) are available. The 29-item Fear of Attacks in Migraine Inventory (FAMI) is an economic self-report questionnaire for the assessment of attack-related fear, and it has good psychometric properties. The treatment of attack-related fear includes behavioral interventions as well as pharmacological therapy. Behavioral interventions have few side effects and are based on the treatment of common anxiety disorders (e.g., agoraphobia). Although the evidence of existing treatments is sparse, attack-related fear should be considered in routine care.

[Galcanezumab for episodic and chronic cluster headache]. / Galcanezumab bei episodischem und chronischem Clusterkopfschmerz.

BACKGROUND: Cluster headache (CH) is a highly debilitating headache disorder characterized by frequent attacks of excruciating unilateral pain accompanied by cranial autonomic symptoms. Calcitonin gene-related peptide (CGRP) is implicated in the pathophysiology of CH. OBJECTIVES: Preventive efficacy and tolerability of the anti-CGRP antibody galcanezumab in patients with episodic (eCH) and chronic CH (cCH). Review of the study results and the challenges in developing drugs for the preventive treatment of CH. MATERIALS AND METHODS: In two international multicenter phase III trials galcanezumab 300 mg given subcutaneously every 4 weeks was compared with placebo. The double-blind study period (8 weeks in eCH, 12 weeks in cCK) was preceded by a baseline period in both trials. The primary endpoint was the reduction in weekly attack frequency. RESULTS: In the eCH trial, 106 patients were randomized to either galcanezumab (n = 49) or placebo (n = 57). The mean weekly attack frequency during the first 3 weeks decreased by 52% in the galcanezumab group compared with 27% in the placebo group (p = 0.036). In the cCH trial, 237 patients were randomized to galcanezumab (n = 117) or placebo (n = 120). The primary endpoint was not met in this study. The reduction in mean weekly attack rate was 5.4 with galcanezumab versus 4.6 with placebo (p = 0.334). Galcanezumab was well tolerated in both studies. CONCLUSIONS: Galcanezumab had a significant effect in the prevention of eCH attacks but not in cCH. Possible reasons for this discrepancy are discussed.

[Consensus statement of the migraine and headache societies (DMKG, ÖKSG, and SKG) on the duration of pharmacological migraine prophylaxis]. / Konsensusstatement der Migräne- und Kopfschmerzgesellschaften (DMKG, ÖKSG & SKG) zur Therapiedauer der medikamentösen Migräneprophylaxe.

Migraine is the most common neurological disorder and can be associated with a high degree of disability. In addition to non-pharmacological approaches to reduce migraine frequency, pharmacological migraine preventatives are available. Evidence-based guidelines from the German Migraine and Headache Society (DMKG), and German Society for Neurology (DGN), Austrian Headache Society (ÖKSG), and Swiss Headache Society (SKG) are available for indication and application. For therapy-relevant questions such as the duration of a pharmacological migraine prevention, no conclusions can be drawn from currently available study data. The aim of this review is to present a therapy consensus statement that integrates the current data situation and, where data are lacking, expert opinions. The resulting current recommendations on the duration of therapy for pharmacological migraine prophylaxis are shown here.

[Consensus statement of the migraine and headache societies (DMKG, ÖKSG, and SKG) on the duration of pharmacological migraine prophylaxis]. / Konsensusstatement der Migräne- und Kopfschmerzgesellschaften (DMKG, ÖKSG & SKG) zur Therapiedauer der medikamentösen Migräneprophylaxe.

Migraine is the most common neurological disorder and can be associated with a high degree of disability. In addition to non-pharmacological approaches to reduce migraine frequency, pharmacological migraine preventatives are available. Evidence-based guidelines from the German Migraine and Headache Society (DMKG), and German Society for Neurology (DGN), Austrian Headache Society (ÖKSG), and Swiss Headache Society (SKG) are available for indication and application. For therapy-relevant questions such as the duration of a pharmacological migraine prevention, no conclusions can be drawn from currently available study data. The aim of this review is to present a therapy consensus statement that integrates the current data situation and, where data are lacking, expert opinions. The resulting current recommendations on the duration of therapy for pharmacological migraine prophylaxis are shown here.

Real-world effectiveness of fremanezumab in patients with migraine switching from another mAb targeting the CGRP pathway: a subgroup analysis of the Finesse Study.

BACKGROUND: Monoclonal antibodies targeting the CGRP pathway are effective and safe for prophylactic treatment of episodic (EM) and chronic migraine (CM). In case of treatment failure of a CGRP pathway targeting mAb, physician has to decide whether using another anti-CGRP pathway mAb is useful. This interim analysis of Finesse Study evaluates effectiveness of the anti-CGRP mAb fremanezumab in patients with a history of other prior anti-CGRP pathway mAb treatments (switch patients). METHODS: FINESSE, a non-interventional, prospective, multicentre, two-country (Germany-Austria) study observing migraine patients receiving fremanezumab in clinical routine. This subgroup analysis presents data on documented effectiveness over 3 months after the first dose of fremanezumab in switch patients. Effectiveness was evaluated based on reduction in average number of migraine days per month (MMDs), MIDAS and HIT-6 scores changes as well as in number of monthly days with acute migraine medication use. RESULTS: One hundred fifty-three out of 867 patients with a history of anti-CGRP pathway mAb treatment prior to initiation of fremanezumab were analysed. Switch to fremanezumab led to ≥ 50% MMD reduction in 42.8% of migraine patients, with higher response rate in EM (48.0%) than in CM patients (36.5%). A ≥ 30% MMD reduction was achieved by 58.7% in CM patients. After three months, monthly number of migraine days decreased by 6.4 ± 5.87 (baseline: 13.6 ± 6.5; p < 0.0001) in all patients, 5.2 ± 4.04 in EM and 7.7 ± 7.45 in CM patients. MIDAS scores decreased from 73.3 ± 56.8 (baseline) to 50.3 ± 52.9 (after 3 months; p = 0.0014), HIT-6 scores decreased from 65.9 ± 5.0 to 60.9 ± 7.2 (p < 0.0001). Concomitant use of acute migraine medication had decreased from 9.7 ± 4.98 (baseline) to 4.9 ± 3.66 (3 months) (p < 0.0001). CONCLUSIONS: Our results show that about 42.8% of anti-CGRP pathway mAb-non-responder benefit from switching to fremanezumab. These results suggest that switching to fremanezumab may be a promising option for patients experiencing poor tolerability or inadequate efficacy with prior other anti-CGRP pathway mAb use. TRIAL REGISTRATION: FINESSE Study is registered on the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS44606).

Headache impact and socioeconomic status: findings from a study of the German Migraine and Headache Society (DMKG).

BACKGOUND: Headache disorders are not only among the most prevalent, they are also among the most disabling disorders worldwide. This paper investigates the association between headache impact on daily life and the socioeconomic status (SES) of headache sufferers. METHODS: Data stem from a random general population sample in Germany. Respondents who reported having headache for at least a year and were aged ≥ 18 years were included in the study. A standardized questionnaire addressing headache and headache treatment was filled in during the face-to-face survey. The impact of headache on daily life was measured using the German version of the Headache Impact Test (HIT-6). RESULTS: Higher headache impact was found in low and medium SES compared to high SES. After adjustment for sociodemographics, headache-related factors (analgesic use, headache duration, headache frequency, migraine diagnosis), depressive symptoms, physical inactivity and obesity, an increased odds ratio of having higher headache impact in low SES compared to high SES was found: OR = 1.83, 95% CI [1.43, 2.23], p = .014. When the interactions "SES*obesity", "SES*depressive symptoms", and "SES*physical inactivity" were added, the results showed a significant interaction effect of "SES*obesity". Obese persons with low SES were 3.64 times more likely to have higher headache impact than non-obese persons with low SES. No significant differences between obese and non-obese persons were found in the medium and high SES groups. CONCLUSIONS: SES is an important factor that should not be neglected in headache awareness campaigns and headache treatment. Longitudinal studies are needed in the future to investigate whether lifestyle interventions, such as weight reduction, can help to reduce headache impact in people in lower SES.

Current treatment options for cluster headache: limitations and the unmet need for better and specific treatments-a consensus article.

AIM: Treatment for cluster headache is currently based on a trial-and-error approach. The available preventive treatment is unspecific and based on few and small studies not adhering to modern standards. Therefore, the authors collaborated to discuss acute and preventive treatment in cluster headache, addressing the unmet need of safe and tolerable preventive medication from the perspectives of people with cluster headache and society, headache specialist and cardiologist. FINDINGS: The impact of cluster headache on personal life is substantial. Mean annual direct and indirect costs of cluster headache are more than 11,000 Euros per patient. For acute treatment, the main problems are treatment response, availability, costs and, for triptans, contraindications and the maximum use allowed. Intermediate treatment with steroids and greater occipital nerve blocks are effective but cannot be used continuously. Preventive treatment is sparsely studied and overall limited by relatively low efficacy and side effects. Neurostimulation is a relevant option for treatment-refractory chronic patients. From a cardiologist's perspective use of verapamil and triptans may be worrisome and regular follow-up is essential when using verapamil and lithium. CONCLUSION: We find that there is a great and unmet need to pursue novel and targeted preventive modalities to suppress the horrific pain attacks for people with cluster headache.

Triptan non-response in specialized headache care: cross-sectional data from the DMKG Headache Registry.

BACKGROUND: Triptans are effective for many migraine patients, but some do not experience adequate efficacy and tolerability. The European Headache Federation (EHF) has proposed that patients with lack of efficacy and/or tolerability of ≥ 2 triptans ('triptan resistance') could be considered eligible for treatment with the novel medications from the ditan and gepant groups. There is little data on the frequency of 'triptan resistance'. METHODS: We used patient self-report data from the German Migraine and Headache Society (DMKG) Headache Registry to assess triptan response and triptan efficacy and/or tolerability failure. RESULTS: A total of 2284 adult migraine patients (females: 85.4%, age: 39.4 ± 12.8 years) were included. 42.5% (n = 970) had failed ≥ 1 triptan, 13.1% (n = 300) had failed ≥ 2 triptans (meeting the EHF definition of 'triptan resistance'), and 3.9% (n = 88) had failed ≥ 3 triptans. Compared to triptan responders (current use, no failure, n = 597), triptan non-responders had significantly more severe migraine (higher frequency (p < 0.001), intensity (p < 0.05), and disability (p < 0.001)), that further increased with the level of triptan failure. Responders rates were highest for nasal and oral zolmitriptan, oral eletriptan and subcutaneous sumatriptan. CONCLUSION: In the present setting (specialized headache care in Germany), 13.1% of the patients had failed ≥ 2 triptans. Triptan failure was associated with increased migraine severity and disability, emphasizing the importance of establishing an effective and tolerable acute migraine medication. Acute treatment optimization might include switching to one of the triptans with the highest responder rates and/or to a different acute medication class. TRIAL REGISTRATION: The DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081).

Long-term open-label safety study of galcanezumab in patients with episodic or chronic cluster headache.

BACKGROUND: CGAR, a Phase 3b open-label study, evaluated the long-term safety of galcanezumab in patients with cluster headache who completed one of two Phase 3 double-blind studies in chronic or episodic cluster headache. METHODS: Patients (N = 164) received galcanezumab 300 mg subcutaneously up to once a month. Primary endpoint was safety, as assessed by treatment-emergent adverse events, serious adverse events, and suicidality. Other endpoints included discontinuation rates, immunogenicity, efficacy as assessed by the Patient Global Impression of Improvement, and health values. RESULTS: At baseline, mean (standard deviation) age was 48.3 (9.8) years, 75.0% were men, and 85.4% were white. Treatment-emergent adverse events (n = 119 [72.6%]) were mostly mild-to-moderate, with nasopharyngitis the most commonly reported (22.0%). One of 18 serious adverse events was judged as treatment related (constipation). Two patients (1.2%) reported suicidal ideation. Five patients (3.1%) discontinued due to an adverse event. Eight patients were treatment-emergent anti-drug antibody positive, two of whom were not treatment-emergent anti-drug antibody positive in the parent studies. On the Patient Global Impression of Improvement, ≥81% reported their cluster headache status as very much, much, or a little better at Months 1, 6, and 12. Health value scores generally improved from baseline. CONCLUSIONS: In this open-label study, galcanezumab was generally well tolerated and improved patient-reported cluster headache status.Trial registration number: NCT02797951; https://clinicaltrials.gov/ct2/show/NCT02797951.

Aspirin, paracetamol (acetaminophen) and caffeine for the treatment of acute migraine attacks: A systemic review and meta-analysis of randomized placebo-controlled trials.

BACKGROUND AND PURPOSE: Many migraine patients rely on over-the-counter analgesics for the treatment of migraine attacks. Fixed-dose combinations of aspirin, paracetamol and caffeine (APC) have been used for treating migraine in many countries for a long time. We performed a meta-analysis for the comparison of APC versus placebo, which has not been done to date. METHODS: Randomized, blinded, placebo-controlled, parallel-group studies using APC to treat a migraine attack were included in a meta-analysis. We calculated the rate ratio (RRs) associated with APC versus placebo. RESULTS: Seven studies were included, with 3306 participants (2147 treated with APC and 1159 treated with placebo). For the primary efficacy outcome, being pain-free at 2 h, APC was superior to placebo (19.6% vs. 9.0%, RR 2.2, 95% confidence interval [CI] 1.4-3.3). For the co-primary efficacy outcome, pain relief at 2 h, APC was superior to placebo (54.3% vs. 31.2%, RR 1.7, 95% CI 1.6-1.9). Adverse events were more frequent in the APC than the placebo groups (10.9% vs. 7.8%, RR 1.7, 95% CI 1.3-2.2). CONCLUSIONS: Results showed that APC is superior to placebo in the treatment of acute migraine attacks. Efficacy, measured by pain-free response and pain relief at 2 h, was clinically relevant.

Is prednisone still a reasonable option in the treatment of withdrawal headache in patients with chronic migraine and medication overuse headache in the age of CGRP antibodies? A narrative review.

OBJECTIVE: Along with the development of novel migraine therapies as the monoclonal antibodies against calcitonin gene-related peptide (CGRP) and its receptor, the question arises if the treatment of chronic migraine (CM) and medication overuse headache (MOH) must be reconsidered. Have previous therapeutic approaches, including glucocorticoids, lost their role in the management of this debilitating disorder? In this narrative review, we present an overview of the available treatment options in CM and MOH in light of CGRP antibodies as well as an evaluation of the role of glucocorticoids in withdrawal therapy. BACKGROUND: Chronic migraine and medication overuse continues to be a difficult to treat condition. To date, potent treatment options are scarce and algorithms for advising patients with MOH are often still based on expert consensus rather than evidence-based medicine. For years and probably due to lack of effective alternatives, glucocorticoids have been used in MOH, especially to alleviate withdrawal symptoms caused by detoxification. Small case series report positive effects of steroids in this respective patient group; however, randomized controlled trials did not show a consistent benefit, although this may be due to methodological limitations. Because of these discrepancies, their role in MOH has been under debate ever since. METHODS: We searched the electronic database PubMed for articles up to June 1, 2022 on the use of glucocorticoids in CM and MOH. CONCLUSION: Despite popular use in clinical practice, there is currently still no scientific evidence for the efficacy of glucocorticoids in patients with CM and MOH. Treatment with monoclonal antibodies achieved high transition rates from medication overuse to non-overuse. However, further research is needed to evaluate the additional benefit of these new agents.

Assessing attack-related fear in headache disorders-Structure and psychometric properties of the Fear of Attacks in Migraine Inventory.

OBJECTIVE: This study aimed to develop a self-report questionnaire for the assessment of attack-related fear in migraine, and to determine its factor structure as well as its psychometric properties by the primary analysis of a cross-sectional survey's data. BACKGROUND: High fear of attacks in migraine increases the burden of disease and is assumed to have a negative impact on the course of the disease. Little is known about the structure and dimensionality of attack-related fear, and a valid instrument for the comprehensive assessment is lacking. METHODS: Based on a literature search and interviews with persons with migraine as well as with experienced practitioners, a 46-item self-report questionnaire, the Fear of Attacks in Migraine Inventory (FAMI) was developed. A cross-sectional online survey comprising an assessment of diagnostic criteria of migraine and a battery of questionnaires including the FAMI was conducted (N = 387 persons with migraine, 364/387 [94.1%] women, M = 40.9 [SD = 13.1] years, migraine without aura: 153/387 [39.5%], migraine with aura: 85/387 [22.0%], and chronic migraine: 149/387 [38.5%]). RESULTS: Item selection led to 29 items for the FAMI. Exploratory factor analysis resulted in three clearly interpretable factors (fear of negative consequences; attention and anticipation; fear-avoidance); a confirmatory factor analysis yielded an acceptable to good model fit (χ2 (3) = 1328.84, p = 0.001, χ2 /df = 3.55, RMSEA = 0.085, SRMR = 0.073, CFI = 0.98, and TLI = 0.97). Reliability was good (fear-avoidance, ω = 0.85; attention and anticipation, ω = 0.88) to excellent (fear of negative consequences, ω = 0.91). Correlational analyses confirmed the convergent validity of the FAMI. CONCLUSIONS: The FAMI appears suitable and promising for the assessment of attack-related fear in migraine research and clinical care.

[Sumatriptan 3 mg subcutaneous : Clinical relevance of acute treatment of migraine despite dose reduction]. / Sumatriptan 3 mg subkutan : Klinische Relevanz in der Akuttherapie der Migräne trotz Dosisreduktion.

BACKGROUND: Triptans are a highly effective substance class in the acute treatment of migraine attacks. They contribute to a substantial improvement in the quality of life and help to reduce the socioeconomic burden of the disease. RESULTS: Sumatriptan is the only triptan that is available for subcutaneous administration. It is primarily indicated in patients with the need for rapid relief or insufficient enteral resorption due to nausea and vomiting. In the treatment of migraine attacks with 6 mg subcutaneous sumatriptan the number needed to treat (NNT) is 2.3 for freedom from pain within 2 h and the NNT is 2.1 for pain relief within 2 h; however, the fast resorption of sumatriptan after subcutaneous administration induces more side effects than the oral route, for example dizziness, paresthesia or chest pressure sensation. CONCLUSION: Clinical studies showed that reducing the subcutaneous dose to 3 mg in migraine treatment has significantly better tolerability with high response rates and freedom from pain within 2 h with 66.7% (3 mg) or 50% (6 mg).

The headache registry of the German Migraine and Headache Society (DMKG): baseline data of the first 1,351 patients.

BACKGROUND: Although good treatment options exist for many headache disorders, not all patients benefit and disability continues to be large. To design strategies for improving headache care, real-world data observing standard care is necessary. Therefore, the German Migraine and Headache Society (DMKG) has established the DMKG Headache Registry. Here we present methods and baseline data. METHODS: Accredited German headache centers (clinic-based or private practice) can offer participation to their patients. Patients provide headache history, current headache load (including a mobile headache diary), medication and comorbidities and answer validated questionnaires, prior to their physician appointment. Physicians use these data as the base of their history taking, and add, change or confirm some central information. Before the next visit, patients are asked to update their data. Patients will continuously be included over the next years. RESULTS: The present analysis is based on the first 1,351 patients (1110 females, 39.6 ± 12.9 years) with a completed first visit. Most participants had a migraine diagnosis. Participants had 14.4 ± 8.5 headache days and 7.7 ± 6.1 acute medication days per month and 63.9% had a migraine disability assessment (MIDAS) grade 4 (severe disability). 93.6% used at least one acute headache medication, most frequently a triptan (60.0%) or non-opioid analgesic (58.3%). 45.0% used at least one headache preventive medication, most frequently an antidepressant (11.4%, mostly amitriptyline 8.4%) or a CGRP(receptor) antibody (9.8%). Most common causes for discontinuation of preventive medication were lack of effect (54.2%) and side effects (43.3%). CONCLUSION: The DMKG Headache Registry allows to continuously monitor headache care at German headache centers in both a cross-sectional and a longitudinal approach. TRIAL REGISTRATION: The DMKG Headache Registry is registered with the German Clinical Trials Register (DRKS 00021081 ).

Status of clinical research in neurology in Germany-A national survey.

BACKGROUND AND PURPOSE: To provide an overview on the status of clinical research in neurology in Germany. METHODS: German university hospitals, nonuniversity hospitals, and neurological medical practices were surveyed regarding their clinical research activities during the period 2013 to 2017. RESULTS: Fifty percent of university hospitals, 10.6% of nonuniversity hospitals, and 5.2% of medical practices in Germany responded to our questionnaire. More than 80% of the clinical studies conducted have been phase III/IV and noninterventional trials (NISs), whereas <1% have been phase I and 3.5% investigator-initiated trials (IITs). University hospitals have conducted most of the phase II-IV trials. NISs have been predominantly performed by medical practices. Fifty-six percent of the university hospitals and less of the nonuniversity institutions confirmed the implementation of standard operating procedures (SOPs). In university hospitals, on average, 11 physicians had acquired a good clinical practice certificate. Overall, 43% of all trials have been performed in neuroimmunology. CONCLUSIONS: The status of clinical research in neurology in Germany is predominated by NISs and late-phase trials, potentially due to a general lack of easily accessible funding, which leads to a highly competitive environment and fewer opportunities to perform early-phase clinical trials as well as IITs. Our results indicate that there is substantial need for structured support for creating and implementing SOPs to maintain quality standards and guarantee uniformity of performance. This survey assessed many aspects of clinical research and serves as guidance for providing ideas for structured improvement of clinical research in neurology in Germany.

Effectiveness of medication in cluster headache.

BACKGROUND: The aim of this work is to analyze the reports on cluster headache attacks collected online in the citizen science project CLUE with respect to the effectiveness of drugs taken during the attacks. The collection of data within the framework of citizen science projects opens up the possibility of investigating the effectiveness of acute medication on the basis of a large number of individual attacks instead of a simple survey of patients. METHODS: Data from 8369 cluster headache attacks, containing information about acute medication taken and the assessment of its effect, were collected from 133 participants using an online platform and a smartphone app. Chi-square tests were used to investigate whether the effect of the three recommended acute drugs differs when distinguishing between participants with chronic or episodic cluster headache. Furthermore, it was investigated whether there are differences between smokers and non-smokers in the assessment of the effect of the acute medication. RESULTS: Our participants rated the effectiveness of sumatriptan 6 mg s.c. as significantly better than oxygen and zolmitriptan nasal spray. Oxygen is considered to be significantly better in episodic versus chronic cluster headache, and sumatriptan is considered to be significantly better in chronic versus episodic cluster headache. Smokers rate the effect of oxygen as significantly better than non-smokers. CONCLUSIONS: Despite some methodological limitations, web-based data collection is able to support findings from clinical trials in a real world setting about effectiveness of acute cluster headache treatment in several situations.