[Current state of knowledge and developments in the prophylaxis and acute treatment of migraine]. / Aktueller Kenntnisstand und Entwicklungen in der akuten und prophylaktischen Therapie der Migräne.

For the acute treatment of the headache phase of a migraine attack, a variety of different pharmacotherapeutic treatment options exist. These range from nonspecifically acting non-opioid analgesics (e.g., paracetamol) and nonsteroidal anti-inflammatory substances (e.g., acetylsalicylic acid, ibuprofen, naproxen, diclofenac) to agents specifically interfering with the serotonin system (ergot alkaloids such as ergotamine and its derivatives, triptans). In patients with significant emesis co-occurring during an attack, additional antiemetics such as metoclopramide or domperidone may be administered. In migraine prophylaxis, largely divergent agents, e.g., ß-adrenoceptor antagonists, Ca-antagonists, or anticonvulsants, are commonly used. The diversity of these compounds may help the treating physician to tailor prophylactic treatment to the patient's individual needs. The treatment success of the individual patient is difficult to predict both in acute and prophylactic migraine treatment. Apart from contraindications or associated side effects of a particular substance, the individual patient's response to treatment is therefore a major determinant in selecting the suitable medication.

[The authorization of clinical trials by the federal authorities]. / Das Genehmigungsverfahren klinischer Prüfungen von Arzneimitteln bei den Bundesoberbehörden.

Since 2004, clinical trials of medicinal products have to be approved by the federal authorities in Germany. Authorization is necessary in addition to the favorable opinion of the concerned ethics committee. This procedure has undoubtedly resulted in larger expenditures with respect to time and costs of planning and conducting of clinical trials. However, the implementation of Good Clinical Practice has also increased both safety for the trial subjects and validity of the data. The most important laws and regulations, definitions, the procedures for submitting a clinical trial application as well as subsequent amendments are described and further information is provided.