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Sponsored by: |
Ipsen |
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Information provided by: | Ipsen |
ClinicalTrials.gov Identifier: | NCT00301665 |
The purpose of this study is to evaluate the efficacy of botulinum toxin type A (Dysport®) injections into pericranial muscles compared to placebo to prevent migraine attacks.
Condition | Intervention | Phase |
---|---|---|
Migraine |
Drug: Botulinum toxin type A |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis |
Estimated Enrollment: | 120 |
Study Start Date: | February 2003 |
Study Completion Date: | March 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Czech Republic | |
General Faculty Hospital | |
Prague 2, Czech Republic, 120 00 | |
University Hospital Hradec Kralove | |
Hradec Kralove, Czech Republic, 50005 | |
St. Anne's Faculty Hospital | |
Brno, Czech Republic, 65691 | |
Poland | |
Medical Academy of Poznan | |
Poznan, Poland, 60-355 | |
City Hospital of Wolomin | |
Wolomin, Poland, 05-200 | |
Air Force Institute of Aviation Medicine | |
Warsaw, Poland | |
Voivodeship (Provincial) Specialist Hospital | |
Zgierz, Poland, 95-100 | |
City Hospital of Wolomin | |
Wolomin, Poland, 05-200 | |
Slovakia | |
Faculty Hospital Bratislava | |
Bratislava, Slovakia, 813 69 | |
Faculty Hospital | |
Martin, Slovakia, 036 01 |
Study Director: | Stefan Lempereur, MD | Ipsen |
Study ID Numbers: | A-38-52120-715 |
Study First Received: | March 9, 2006 |
Last Updated: | September 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00301665 History of Changes |
Health Authority: | Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Czech Republic: State Institute for Drug Control |
Botulinum Toxins Migraine Disorders Headache Central Nervous System Diseases Headache Disorders, Primary |
Peripheral Nervous System Agents Botulinum Toxin Type A Brain Diseases Headache Disorders |
Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Central Nervous System Diseases Headache Disorders, Primary Neuromuscular Agents Brain Diseases Pharmacologic Actions |
Headache Disorders Botulinum Toxins Migraine Disorders Therapeutic Uses Peripheral Nervous System Agents Botulinum Toxin Type A Central Nervous System Agents |