Back to resultsEfficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
Primary Purpose
Migraine
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional prevention trial for Migraine
Eligibility 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
Sites / Locations
- St. Anne's Faculty Hospital
- University Hospital Hradec Kralove
- General Faculty Hospital
- Medical Academy of Poznan
- Air Force Institute of Aviation Medicine
- City Hospital of Wolomin
- Voivodeship (Provincial) Specialist Hospital
- Faculty Hospital Bratislava
- Faculty Hospital
Outcomes
Primary Outcome Measures
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00301665
Brief Title
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
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 Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
138 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Reduction of the intensity of the migraine attacks.
Time Frame
3 months
Title
Reduction of duration of the migraine attacks.
Time Frame
3 months
Title
Reduction of migraine medication consumption.
Time Frame
3 months
Title
Improvement of quality of life.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
St. Anne's Faculty Hospital
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czechia
Facility Name
General Faculty Hospital
City
Prague 2
ZIP/Postal Code
120 00
Country
Czechia
Facility Name
Medical Academy of Poznan
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Air Force Institute of Aviation Medicine
City
Warsaw
Country
Poland
Facility Name
City Hospital of Wolomin
City
Wolomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
Voivodeship (Provincial) Specialist Hospital
City
Zgierz
ZIP/Postal Code
95-100
Country
Poland
Facility Name
Faculty Hospital Bratislava
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Faculty Hospital
City
Martin
ZIP/Postal Code
036 01
Country
Slovakia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
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