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Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
This study has been completed.
Sponsor:
Ipsen
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00301665
First received: March 9, 2006
Last updated: September 12, 2007
Last verified: September 2007
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Phase II, Multicentre, Randomised, Double-Blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis |
Resource links provided by NLM:
Further study details as provided by Ipsen:
Primary Outcome Measures:
- Significant decrease of the number of migraine attacks with Dysport® compared to placebo. [ Time Frame: 3 months ]
Secondary Outcome Measures:
- Reduction of the intensity of the migraine attacks. [ Time Frame: 3 months ]
- Reduction of duration of the migraine attacks. [ Time Frame: 3 months ]
- Reduction of migraine medication consumption. [ Time Frame: 3 months ]
- Improvement of quality of life. [ Time Frame: 3 months ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2003 |
| Study Completion Date: | March 2005 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301665
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301665
Locations
| Czech Republic | |
| St. Anne's Faculty Hospital | |
| Brno, Czech Republic, 65691 | |
| University Hospital Hradec Kralove | |
| Hradec Kralove, Czech Republic, 50005 | |
| General Faculty Hospital | |
| Prague 2, Czech Republic, 120 00 | |
| Poland | |
| Medical Academy of Poznan | |
| Poznan, Poland, 60-355 | |
| Air Force Institute of Aviation Medicine | |
| Warsaw, Poland | |
| City Hospital of Wolomin | |
| Wolomin, Poland, 05-200 | |
| Voivodeship (Provincial) Specialist Hospital | |
| Zgierz, Poland, 95-100 | |
| Slovakia | |
| Faculty Hospital Bratislava | |
| Bratislava, Slovakia, 813 69 | |
| Faculty Hospital | |
| Martin, Slovakia, 036 01 | |
Sponsors and Collaborators
Ipsen
Investigators
| Study Director: | Stefan Lempereur, MD | Ipsen |
More Information
| ClinicalTrials.gov Identifier: | NCT00301665 History of Changes |
| Other Study ID Numbers: |
A-38-52120-715 |
| Study First Received: | March 9, 2006 |
| Last Updated: | September 12, 2007 |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA onabotulinumtoxinA |
incobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 18, 2017