Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

This study has been completed.

First Received: March 9, 2006 Last Updated: September 12, 2007 History of Changes

Sponsored by:	Ipsen
Information provided by:	Ipsen
ClinicalTrials.gov Identifier:	NCT00301665

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 II

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Botox Migraine

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II, Multicentre, Randomised, Double-Blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00301665

Locations

Czech Republic
General Faculty Hospital
Prague 2, Czech Republic, 120 00
University Hospital Hradec Kralove
Hradec Kralove, Czech Republic, 50005
St. Anne's Faculty Hospital
Brno, Czech Republic, 65691
Poland
Medical Academy of Poznan
Poznan, Poland, 60-355
City Hospital of Wolomin
Wolomin, Poland, 05-200
Air Force Institute of Aviation Medicine
Warsaw, Poland
Voivodeship (Provincial) Specialist Hospital
Zgierz, Poland, 95-100
City Hospital of Wolomin
Wolomin, Poland, 05-200
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

Study ID Numbers:	A-38-52120-715
Study First Received:	March 9, 2006
Last Updated:	September 12, 2007
ClinicalTrials.gov Identifier:	NCT00301665 History of Changes
Health Authority:	Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Botulinum Toxins
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary

Peripheral Nervous System Agents
Botulinum Toxin Type A
Brain Diseases
Headache Disorders

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Headache Disorders, Primary
Neuromuscular Agents
Brain Diseases
Pharmacologic Actions

Headache Disorders
Botulinum Toxins
Migraine Disorders
Therapeutic Uses
Peripheral Nervous System Agents
Botulinum Toxin Type A
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009