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 Chronic Migraine in Adult Participants
Study on Investigational Medication for Preventing Chronic Migraine in Adults Using Botulinum Toxin Type A
Marlene Bultemeher
Primary Investigator
Brief description of study
The purpose of this study is to understand the safety and effectiveness of the study drug, Dysport® when compared with placebo in preventing chronic 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.
Chronic migraine is defined as having at least 15 days of headache a month with at least 8 of those days being migraine headache days.
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.
Detailed description of study
The study will consist of 3 periods:
- A 'screening period' of 6 to 12 weeks to assess whether the participant can take part to the study and requires 1 visit.
- 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 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.
- 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).
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Migraine
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria :
- Participant must be ≥18 years of age inclusive, at the time of signing the informed consent and privacy/data protection documentation
- Participant has a diagnosis for more than 12 months, prior to screening visit, of chronic migraine according to the International Classification of Headache Disorders definition and diagnostic criteria
- Migraine onset occurred when participant was <50 years of age
- Has baseline number of monthly headache days (MHD) ≥15 and baseline number of monthly migraine days (MMD) of ≥8, using eDiary data collected during the 4 weeks nearest to randomisation on Day 1 (but prior to randomisation)
- Has baseline number of valid diary days ≥22 days collected during the 4 weeks nearest to randomisation on Day 1
Exclusion Criteria :
- History or current diagnosis of migraine with brainstem aura, retinal migraine, complications of migraine, tension-type headache, trigeminal autonomic cephalalgias, hypnic headache, hemicrania continua, or new daily persistent headache
- Headache attributed to another disorder (e.g. secondary headaches), except medication overuse headache, which is permitted
- Use of any of the following medications in the specified timeframe prior to start of completion of the screening daily headache eDiary:
- Within 24 weeks
- i. Botulinum toxin for migraine (or for any other medical/aesthetic reason within 16 weeks)
- Within 12 weeks
- i. CGRP antagonists (monoclonal antibody or gepant) for preventive treatment of migraine (acute treatment of headache/migraine with a gepant is permitted)ii. Cannabidiol or other types of cannabinoids
- Within 4 weeks
- i. Anaesthetic or steroid injection in any region targeted for injection with study intervention
- ii. Use of medical device to treat migraine (e.g. non-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation, and peripheral neuroelectrical stimulation)
- iii. Other interventions for migraine assessed to interfere with study evaluations (e.g. acupuncture in head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments, and dental splints for headache) iv. Use of opioids or barbiturates for more than 2 days/month. Note: participants are permitted to take one concomitant migraine preventative treatment (not listed above); however, the dose of this medication should be stable for ≥3 months before start of the screening eDiary
- Within 24 weeks
This study investigates the effectiveness and safety of an investigational medication compared to a placebo in preventing chronic migraine in adults. A migraine is a severe headache with throbbing pain usually on one side of the head, often accompanied by nausea and sensitivity to light and sound. Chronic migraine is defined as having at least 15 headache days a month, with at least 8 of those being migraine days. The investigational medication is a form of Botulinum toxin type A, which works by stopping the release of chemicals that cause pain.
Participants in the study will undergo several procedures, including injections into various muscles in the head, neck, face, and shoulders. These injections will contain either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. Participants will also need to complete an e-diary, questionnaires, and undergo blood and urine tests, physical exams, and clinical evaluations. Some medications may be continued, but they need to be recorded.
- Who can participate: Adults aged 18 and older who have had a diagnosis of chronic migraine for more than 12 months can participate. Participants must have at least 15 headache days per month, with at least 8 being migraine days. They should not have certain types of migraines or be using specific medications that could interfere with the study.
- Study details: Participants will receive injections and complete an e-diary and questionnaires. They will also undergo blood and urine tests, physical exams, and clinical evaluations (medical assessments to check health status). A placebo, an inactive substance that looks like the investigational medicine, will be used for comparison.
- Study timelines and visits: The study will last 60 weeks. The study requires 12 visits.
