Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
1 other identifier
interventional
138
3 countries
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2003
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 9, 2006
CompletedFirst Posted
Study publicly available on registry
March 13, 2006
CompletedApril 24, 2020
April 1, 2020
March 9, 2006
April 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
3 months
Secondary Outcomes (4)
Reduction of the intensity of the migraine attacks.
3 months
Reduction of duration of the migraine attacks.
3 months
Reduction of migraine medication consumption.
3 months
Improvement of quality of life.
3 months
Interventions
Eligibility Criteria
You may qualify if:
- 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
- to 6 migraine attacks of at least moderate severity during the screening period
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ipsenlead
Study Sites (9)
St. Anne's Faculty Hospital
Brno, 65691, Czechia
University Hospital Hradec Kralove
Hradec Králové, 50005, Czechia
General Faculty Hospital
Prague, 120 00, Czechia
Medical Academy of Poznan
Poznan, 60-355, Poland
Air Force Institute of Aviation Medicine
Warsaw, Poland
City Hospital of Wolomin
Wołomin, 05-200, Poland
Voivodeship (Provincial) Specialist Hospital
Zgierz, 95-100, Poland
Faculty Hospital Bratislava
Bratislava, 813 69, Slovakia
Faculty Hospital
Martin, 036 01, Slovakia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ipsen Medical Director
Ipsen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2006
First Posted
March 13, 2006
Study Start
February 1, 2003
Study Completion
March 1, 2005
Last Updated
April 24, 2020
Record last verified: 2020-04