Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00301665
• Other study ID #: A-38-52120-715
• Status: Completed
• Phase: Phase 2
• Start date: February 2003
• Est. completion date: March 2005

Study information

• Verified date: April 2020
• Source: Ipsen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Biological:
• Botulinum toxin type A

Locations

Country	Name	City	State
Czechia	St. Anne's Faculty Hospital	Brno
Czechia	University Hospital Hradec Kralove	Hradec Kralove
Czechia	General Faculty Hospital	Prague 2
Poland	Medical Academy of Poznan	Poznan
Poland	Air Force Institute of Aviation Medicine	Warsaw
Poland	City Hospital of Wolomin	Wolomin
Poland	Voivodeship (Provincial) Specialist Hospital	Zgierz
Slovakia	Faculty Hospital Bratislava	Bratislava
Slovakia	Faculty Hospital	Martin

Sponsors (1)

Lead Sponsor	Collaborator
Ipsen

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Significant decrease of the number of migraine attacks with Dysport® compared to placebo.		3 months
Secondary	Reduction of the intensity of the migraine attacks.		3 months
Secondary	Reduction of duration of the migraine attacks.		3 months
Secondary	Reduction of migraine medication consumption.		3 months
Secondary	Improvement of quality of life.		3 months