Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00301665
• Date of registration: 09/03/2006
• Prospective Registration: No
• Primary sponsor: Ipsen
• Public title: Efficacy and Safety Study of Dysport® Used for Migraine Prophylaxis
• Scientific title: A Phase II, Multicentre, Randomised, Double-blind, Parallel Groups, Placebo Controlled Clinical Study of Efficacy and Safety of Dysport® for Migraine Prophylaxis
• Date of first enrolment: February 2003
• Target sample size: 138
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00301665
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double.
• Phase: Phase 2

Countries of recruitment

Czech Republic, Czechia, Poland, Slovakia

Contacts

• Name: Ipsen Medical Director
• Affiliation: Ipsen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Migraine

Intervention(s)

Biological: Botulinum toxin type A

Primary Outcome(s)

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

Secondary Outcome(s)

Reduction of the intensity of the migraine attacks. [Time Frame: 3 months]

Reduction of migraine medication consumption. [Time Frame: 3 months]

Reduction of duration of the migraine attacks. [Time Frame: 3 months]

Improvement of quality of life. [Time Frame: 3 months]

Secondary ID(s)

A-38-52120-715

Source(s) of Monetary Support

Please refer to primary and secondary sponsors