Evaluation and Registration of Adverse Events in Clinical Drug Trials in Migraine-Reference-Cited by-同舟云学术

Evaluation and Registration of Adverse Events in Clinical Drug Trials in Migraine

Published:2008-07 Issue:7 Volume:28 Page:683-688
ISSN:0333-1024
Container-title:Cephalalgia
language:en
Short-container-title:Cephalalgia

Author:

Tfelt-Hansen P¹,Bjarnason NH²,Dahlöf C³,Derry S⁴,Loder E⁵,Massiou H⁶,

Affiliation:

1. Danish Headache Centre, Department of Neurology, University of Copenhagen, Glostrup Hospital, Copenhagen

2. Department of Clinical Pharmacology, Gentofte Hospital, Gentofte, Denmark

3. Gothenborg Headache Clinic and Institute of Neuroscience and Physiology, Sahlgrenska University Hospital, Gothenborg, Sweden

4. Pain Research and Nuffield Department of Anaesthetics, University of Oxford, Oxford, UK

5. Department of Neurology, Brigham and Women's/Faulkner Hospital, Harvard Medical School, Boston, MA, USA

6. Department of Neurology, Lariboisière Hospital, Paris, France

Abstract

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.

Publisher

SAGE Publications

Subject

Clinical Neurology,General Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1111/j.1468-2982.2008.01600.x

Reference24 articles.

1. Guidelines for Controlled Trials of Drugs in Migraine: Second Edition

2. Topiramate for Migraine PreventionA Randomized Controlled Trial

3. Topiramate in Migraine Prevention

4. Low-dose topiramate in adults with treatment-resistant partial-onset seizures

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