E-BEOND
Research type
Research Study
Full title
A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, Parallel-group Study with Extension Phase to Evaluate the Efficacy and Safety of Dysport® for the Prevention of Episodic Migraine in Adult Participants
IRAS ID
1009328
Contact name
Ipsen Clinical Study Enquiries N/A
Contact email
Sponsor organisation
Ipsen Innovation
Clinicaltrials.gov Identifier
Research summary
A migraine is a headache with severe throbbing pain or a pulsing sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound.
Episodic migraine is defined as having a migraine headache at least 8 times a month and experiencing migraine headache between 1 to 14 days in a month.
The study drug being tested is Dysport®, a botulinum toxin type A (BoNT-A) naturally produced by a certain type of bacteria, which has already been approved as a medicine in over 90 countries for different medical conditions. A neurotoxin is a substance which relaxes muscles by acting on and altering the function of the nervous system. This kind of toxin has been shown to have the potential to reduce migraine headaches and disease burden in adults with frequent migraines. In this study, two doses of Dysport®, or placebo (dummy drug) will be injected into muscles in the face, head and neck.
Ipsen Innovation are sponsoring this Phase III research study to test how well Dysport® works and how safe it is compared with placebo in preventing or decreasing migraines.
Approximately 720 participants will be included in this study and will be randomly assigned to one of the following treatment sequences:
4 cycles of Dysport® Dose A
4 cycles of Dysport® Dose B
2 cycles of Placebo followed by 2 cycles of Dysport® Dose A
2 cycles of Placebo followed by 2 cycles of Dysport® Dose B
Participants will have 2 out of 3 chances to receive Dysport® from the first administration.The study will take place at about 98 study sites in 9 countries (Canada, Czech Republic, Germany, Georgia, Italy, Poland, Spain, UK and USA). Participants will be in the study for 54 to 60 weeks.
REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0040
Date of REC Opinion
27 Feb 2024
REC opinion
Further Information Favourable Opinion