Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
Information source: Ipsen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine
Intervention: Botulinum toxin type A (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Ipsen Official(s) and/or principal investigator(s):
Stefan Lempereur, MD, Study Director, Affiliation: Ipsen
Summary
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.
Clinical Details
Official title: A Phase II, Multicentre, Randomised, Double-Blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
Secondary outcome: Reduction of the intensity of the migraine attacks.Reduction of duration of the migraine attacks. Reduction of migraine medication consumption. Improvement of quality of life.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients having migraine without aura or with typical aura as defined by International
Headache Society criteria
- Migraine attacks have been persisting for more than 1 year
- 2 to 6 migraine attacks per month of at least moderate severity over the 3 months
preceding the pre-inclusion visit
- 2 to 6 migraine attacks of at least moderate severity during the screening period
Exclusion Criteria:
- Non-migraine headaches such as tension-type headaches
- Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migraine
aura without headache, migraine with acute onset aura, ophthalmoplegic migraine,
retinal migraine, complications of migraine
- Onset of migraine is after age of 50
- Overuse of acute migraine medications (individuals who take medications for acute
migraine more than 10 days per month) or have a history of drug or alcohol abuse
Locations and Contacts
General Faculty Hospital, Prague 2 120 00, Czech Republic
University Hospital Hradec Kralove, Hradec Kralove 50005, Czech Republic
St. Anne's Faculty Hospital, Brno 65691, Czech Republic
Medical Academy of Poznan, Poznan 60-355, Poland
City Hospital of Wolomin, Wolomin 05-200, Poland
Air Force Institute of Aviation Medicine, Warsaw, Poland
Voivodeship (Provincial) Specialist Hospital, Zgierz 95-100, Poland
City Hospital of Wolomin, Wolomin 05-200, Poland
Faculty Hospital Bratislava, Bratislava 813 69, Slovakia
Faculty Hospital, Martin 036 01, Slovakia
Additional Information
Starting date: February 2003
Ending date: March 2005
Last updated: September 12, 2007
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