Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

April 23, 2020 updated by: Ipsen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

138

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 65691
        • St. Anne's Faculty Hospital
      • Hradec Kralove, Czechia, 50005
        • University Hospital Hradec Kralove
      • Prague 2, Czechia, 120 00
        • General Faculty Hospital
  • Poland
      • Poznan, Poland, 60-355
        • Medical Academy of Poznan
      • Warsaw, Poland
        • Air Force Institute of Aviation Medicine
      • Wolomin, Poland, 05-200
        • City Hospital of Wolomin
      • Zgierz, Poland, 95-100
        • Voivodeship (Provincial) Specialist Hospital
  • Slovakia
      • Bratislava, Slovakia, 813 69
        • Faculty Hospital Bratislava
      • Martin, Slovakia, 036 01
        • Faculty Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Significant decrease of the number of migraine attacks with Dysport® compared to placebo.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduction of the intensity of the migraine attacks.
Time Frame: 3 months
3 months
Reduction of duration of the migraine attacks.
Time Frame: 3 months
3 months
Reduction of migraine medication consumption.
Time Frame: 3 months
3 months
Improvement of quality of life.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ipsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Study Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

March 9, 2006

First Submitted That Met QC Criteria

March 9, 2006

First Posted (ESTIMATE)

March 13, 2006

Study Record Updates

Last Update Posted (ACTUAL)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-38-52120-715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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