Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00301665
First received: March 9, 2006
Last updated: September 12, 2007
Last verified: September 2007
  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
Endpoint Classification: Safety/Efficacy Study
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
Genders Eligible for Study:   Both
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

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

No publications provided

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
Health Authority: Poland: Ministry of Health
Slovakia: State Institute for Drug Control
Czech Republic: State Institute for Drug Control

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
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014