Ipsen
The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing episodic migraine. A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head, and is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Episodic Migraine is defined as having less than 15 days of headache a month with at least 6 days with migraine headaches. Migraines are caused by a series of events which cause the brain to get stimulated / activated, which results in the release of chemicals that cause pain. Dysport® is a formulation of Botulinum toxin type A (BoNT-A), a medication that stops the release of these chemical messengers. The study will consist of 3 periods: 1. A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit. 2. A first Treatment Phase of 24 weeks. On Day 1 and at Week 12 of the first Treatment Phase, participants will receive injections into various muscles across the head, neck, face and shoulders. The injections will contain either a dose "A" or a dose ''B'' of Dysport® or a placebo (an inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied). Participants will make 4 visits to the clinic in person and have 4 remote (online) visits. 3. A second Treatment Phase of 24 weeks (extension phase). At Week 24 and at Week 36, all participants will get Dysport® (dose "A" or dose "B"). There will be 3 in person visits and 4 remote visits. Participants will need to complete an e-diary and questionnaires throughout the study. Participants will undergo blood samplings, urine collections, physical examinations, and clinical evaluations. They may continue some other medications, but the details need to be recorded. The total study duration for a participant will be up to 60 weeks (approx. 14 months).
Episodic Migraine
Botulinum toxin type A
Botulinum toxin type A
Placebo
Botulinum toxin type A
Botulinum toxin type A
PHASE3
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 714 participants |
Masking : | DOUBLE |
Primary Purpose : | PREVENTION |
Official Title : | A Phase III, Randomised, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study With Extension Phase to Evaluate the Efficacy and Safety of Dysport® for the Prevention of Episodic Migraine in Adult Participants |
Actual Study Start Date : | 2023-09-29 |
Estimated Primary Completion Date : | 2026-06-22 |
Estimated Study Completion Date : | 2026-12-21 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
840024
Birmingham, Alabama, United States, 35205
RECRUITING
840018
Phoenix, arizona, United States, 85044
NOT YET RECRUITING
840034
Scottsdale, arizona, United States, 85251
RECRUITING
840027
Tempe, arizona, United States, 85281
RECRUITING
840030
Fullerton, California, United States, 92835
RECRUITING
840039
Fullerton, California, United States, 92835
RECRUITING
840010
Orange, California, United States, 92868
RECRUITING
840037
Savannah, California, United States, 31406
RECRUITING
840023
Aventura, Florida, United States, 33180
RECRUITING
840004
Hialeah, Florida, United States, 33012
RECRUITING
840013
Hollywood, Florida, United States, 33024
RECRUITING
840032
Tampa, Florida, United States, 33614
RECRUITING
840051
Winter Park, Florida, United States, 32131
RECRUITING
840052
Winter Park, Florida, United States, 32789
RECRUITING
840038
Savannah, Georgia, United States, 31406
ACTIVE NOT RECRUITING
840035
Riverwoods, Illinois, United States, 60015
RECRUITING
840021
Fort Wayne, Indiana, United States, 46804
RECRUITING
32789
Boston, Massachusetts, United States, 02131
NOT YET RECRUITING
840031
Burnsville, Minnesota, United States, 55337
RECRUITING
840017
Chesterfield, Missouri, United States, 63005
RECRUITING
840001
Brooklyn, New York, United States, 11235
RECRUITING
840014
Poughkeepsie, New York, United States, 12601
RECRUITING
840009
Rochester, New York, United States, 14609
RECRUITING
840033
Asheville, North Carolina, United States, 28806
ACTIVE NOT RECRUITING
840005
Hendersonville, North Carolina, United States, 28792
ACTIVE NOT RECRUITING
840026
New Albany, Ohio, United States, 43054
RECRUITING
840022
Philadelphia, Pennsylvania, United States, 19107
NOT YET RECRUITING
840008
Cordova, Tennessee, United States, 38018
RECRUITING
840025
Frisco, Texas, United States, 75034
RECRUITING
840012
Houston, Texas, United States, 77074
RECRUITING
840007
Plano, Texas, United States, 75093
RECRUITING
840036
Salt Lake City, Utah, United States, 84109
RECRUITING
840015
West Valley City, Utah, United States, 84119
RECRUITING
840020
Columbia, Washington, United States, 20010
RECRUITING
124004
Red Deer, Canada,
RECRUITING
124003
Sarnia, Canada, N7T 4X3
RECRUITING
203008
Brno, Czechia,
NOT YET RECRUITING
203001
Chocen, Czechia,
RECRUITING
203005
Jihlava, Czechia,
NOT YET RECRUITING
203003
Prague 8, Czechia,
RECRUITING
203006
Prague, Czechia,
NOT YET RECRUITING
250002
Amiens, France,
NOT YET RECRUITING
250003
Nimes, France,
NOT YET RECRUITING
250001
Paris, France,
RECRUITING
268002
Batumi, Georgia, 6010
RECRUITING
268003
Tbilisi, Georgia, 0114
RECRUITING
268006
Tbilisi, Georgia, 0114
RECRUITING
268005
Tbilisi, Georgia, 0179
RECRUITING
268001
Tbilisi, Georgia, 0186
RECRUITING
276002
Berlin, Germany,
NOT YET RECRUITING
276007
Berlin, Germany,
NOT YET RECRUITING
276003
Greifswald, Germany,
NOT YET RECRUITING
276001
München, Germany,
NOT YET RECRUITING
616004
Bydgoszcz, Poland,
RECRUITING
616001
Gdynia, Poland,
NOT YET RECRUITING
616006
Katowice, Poland,
RECRUITING
616003
Krakow, Poland,
RECRUITING
616005
Krakow, Poland,
NOT YET RECRUITING
616007
Krakow, Poland,
NOT YET RECRUITING
616002
Lublin, Poland,
NOT YET RECRUITING
616008
Auschwitz, Poland,
NOT YET RECRUITING
724002
Madrid, Spain,
NOT YET RECRUITING
724005
Madrid, Spain,
NOT YET RECRUITING
724001
Málaga, Spain,
NOT YET RECRUITING
724003
Valencia, Spain,
NOT YET RECRUITING
724004
Zaragoza, Spain,