IM ketorolac vs diclofenac potassium powder for oral solution for the acute treatment of severe migraine: a randomized controlled trial.

BACKGROUND: Diclofenac potassium for oral solution (CAMBIA®) may be an alternative for patients who would otherwise need to be seen in a healthcare setting for parenteral ketorolac. CAMBIA® is FDA-approved for the abortive treatment of migraine and has demonstrated superiority over generic diclofenac tablets with rapid migraine reduction. This study assessed for efficacy of CAMBIA® as an alternative outpatient treatment for refractory migraine to parenteral ketorolac. METHODS: We performed an exploratory, single-center, double-blind, double-dummy randomized controlled trial comparing CAMBIA® with IM ketorolac. Participants were randomized to receive either ketorolac 60 mg IM with dummy oral solution or CAMBIA® 50 mg, together with IM injection of normal saline. The primary endpoint was headache severity, self-rated on a scale 0-3. Secondary endpoints included self-rated nausea, disability, and photo- or phonophobia, as well as presence of side effects and need for additional rescue therapy. RESULTS: A total of 23 patients were enrolled. Ten patients received the study drug and 13 patients received IM ketorolac as the control. There were no major differences observed with respect to the primary outcome of mean headache severity at successive time points over a 24-h follow-up period. No major differences were found with respect to average disability, nausea, and photo- or phonophobia ratings. No major adverse events were reported. CONCLUSION: In treatment of refractory migraine headache, CAMBIA® may provide similar benefits as IM ketorolac without increasing the risk of treatment failure, major bleeding, or cardiovascular events. However, larger studies are needed to confirm this finding. TRIAL REGISTRATION: Clinicaltrials.gov: NCT # 02664116, Titled "IM Ketorolac vs Diclofenac Potassium Powder for Oral Solution (CAMBIA®) for the Acute Treatment of Severe Migraine". Registered 26 January 2016, https://clinicaltrials.gov/ct2/show/NCT02664116?term=02664116&rank=1.

A prospective, open-label study of milnacipran in the prevention of headache in patients with episodic or chronic migraine.

Migraine is a highly prevalent episodic and chronic neurological disorder that impacts otherwise healthy men and women in their most productive years. An anecdotal survey in our clinical practices suggested that milnacipran, a drug indicated for the treatment of fibromyalgia, reduced the incidence of headache in patients with migraine. In this 3-month, open-label, pilot study, 38 patients diagnosed with episodic migraine and 7 patients with chronic migraine maintained headache diaries to assess the effectiveness and tolerability of milnacipran in headache prevention. After a 1-month period to obtain baseline data, milnacipran treatment was initiated and doses were titrated up to 100 mg/day over 1 month. Maintenance therapy continued for an additional 3 months. The primary efficacy end point was change from baseline in the number of all headache days during the last 28 days of maintenance therapy analyzed, using last observation carried forward (LOCF). Change from baseline in migraine days during the last month of the maintenance period using LOCF was a secondary end point. Milnacipran 100 mg daily was associated with a significant reduction in headache (-4.2 days; P < 0.001) and migraine frequency (-2.2 days; P < 0.003). The adverse event profile was consistent with prior reports of milnacipran for the treatment of other conditions. However, compared with the recommended protocol, a more gradual increase in milnacipran dose was required to improve tolerability for some patients. The robust efficacy signal found in this study strongly suggests that a double-blind, placebo-controlled trial of milnacipran in migraine and chronic headache is warranted.

Fremanezumab-associated injection site alopecia.

Calcitonin gene-related peptide (CGRP) inhibitors, in the form of injectable monoclonal antibodies, are a newer class of drugs for the prevention of migraine headaches. In clinical trials, they have been found to be effective with good tolerance and few adverse effects. Alopecia has been increasingly noted as a post-marketing event associated with CGRP inhibitor injectables. Of the case reports available on this topic, alopecia has commonly been localised to the scalp and associated with erenumab use; however, not as much has been reported for fremanezumab nor for injection site-related alopecia. We report an occurrence of persistent lower extremity localised injection site alopecia in a patient within our headache clinic who used fremanezumab. The possible mechanism of alopecia may be related to the failure of hair follicle immune privilege in the absence of CGRP immunomodulatory effects.

Amelioration of trichotillomania with onabotulinumtoxinA for chronic migraine.

We report a case of a woman in her 30s who struggled with a life-long history of trichotillomania (TTM; hair-pulling disorder), which was unsuccessfully treated with behavioural therapy and selective serotonin reuptake inhibitors. In addition to TTM, our patient had a history of chronic migraine which brought her to our clinic, and treatment with onabotulinumtoxinA (OBTA) was initiated per the Phase III REsearch Evaluating Migraine Prophylaxis Therapy protocol. After experiencing improvement with migraine symptoms, she began off-label treatment with OBTA for her TTM with 45 units being injected, 5 units per site, in diffuse regions of her scalp, primarily on the affected areas of TTM-induced alopecia. The patient reported marked improvement in her TTM signs and symptoms, which resulted in hair regrowth as early as the first follow-up visit 12 weeks post-treatment initiation. Treatment effects were maintained, and additional hair regrowth was observed at the 1-year post-treatment visit, which equated to four cycles of treatment.