Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00301665
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : September 14, 2007
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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.

Condition or disease Intervention/treatment Phase
Migraine Drug: Botulinum toxin type A Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : February 2003
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Migraine
U.S. FDA Resources

Primary Outcome Measures :
  1. Significant decrease of the number of migraine attacks with Dysport® compared to placebo. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Reduction of the intensity of the migraine attacks. [ Time Frame: 3 months ]
  2. Reduction of duration of the migraine attacks. [ Time Frame: 3 months ]
  3. Reduction of migraine medication consumption. [ Time Frame: 3 months ]
  4. Improvement of quality of life. [ Time Frame: 3 months ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00301665

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
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
Faculty Hospital Bratislava
Bratislava, Slovakia, 813 69
Faculty Hospital
Martin, Slovakia, 036 01
Sponsors and Collaborators
Study Director: Stefan Lempereur, MD Ipsen Identifier: NCT00301665     History of Changes
Other Study ID Numbers: A-38-52120-715
First Posted: March 13, 2006    Key Record Dates
Last Update Posted: September 14, 2007
Last Verified: September 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
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