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Completed

NCT Number: NCT00301665

Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

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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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Anne's Faculty Hospital, Brno, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. Significant decrease of the number of migraine attacks with Dysport® compared to placebo.

    Time frame: 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study title

A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis

Important dates

Study start
2003
Study completion
2005
First posted
Mar 13, 2006
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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