Evaluation and registration of adverse events in clinical drug trials in migraine.

• Tolerability of a drug should be regarded as important as its efficacy. In all four phases of drug development evaluation of adverse events is important. Recommendations for assessment of adverse events in acute and prophylactic clinical drug trials in migraine are given. Tolerability may be indirectly assessed using measures of general well-being and eight such tools are presented. Finally, recommendations for reporting of adverse events are given.

Keyword

Adverse Drug Reaction Reporting Systems

Analgesics

adverse effects

therapeutic use

Cross-Over Studies

Dose-Response Relationship

Drug

Double-Blind Method

Drug Administration Schedule

Humans

Migraine Disorders

drug therapy

Randomized Controlled Trials as Topic

Registries

Publication and Content Type

ref (subject category)

art (subject category)