Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Botulinum toxin type A

Intervention Type BIOLOGICAL

Other Intervention Names

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AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No