A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults
- Conditions
- Episodic Migraine
- Interventions
- Other: Placebo
- Registration Number
- NCT06047457
- Lead Sponsor
- Ipsen
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 714
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo - Dysport dose "A" Placebo Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48). Placebo - Dysport dose "B" Placebo Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48). Dysport® dose "A" Botulinum toxin type A Participant will receive four treatment cycles, each separated by an interval of 12 weeks. Double-blind placebo-controlled (DBPC) Phase: Dysport® dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48) Dysport® dose "B" Botulinum toxin type A Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Dysport® dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48) Placebo - Dysport dose "A" Botulinum toxin type A Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "A" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "A" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48). Placebo - Dysport dose "B" Botulinum toxin type A Participant will receive four treatment cycles, each separated by an interval of 12 weeks. DBPC Phase: Placebo dose "B" administered intramuscularly on Day 1 and Week 12. Extension Phase: Dysport® dose "B" administered intramuscularly at Week 24 and Week 36 (final follow-up at Week 48).
- Primary Outcome Measures
Name Time Method Change from baseline in monthly migraine days (MMD) Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The monthly migraine days (MMD) is assessed by a daily eDiary, completed by the participant, to evaluate the efficacy of Dysport® compared to placebo.
- Secondary Outcome Measures
Name Time Method Headache medication overuser (yes, no) Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The headache medication overuse will be assessed by a concomitant medication log completed at each visit and acute medication taken to treat acute attack will be recorded in the daily eDiary. The headache medication overuse is defined as a participant with ≥10 days/month if ergotamine, triptan, gepant, ditan, opioid or combination analgesic, or ≥15 days/month if non-opioid analgesic (such as paracetamol, aspirin, NSAID)
Cumulative number of MMD From Day 1 to Week 24 The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.
Change from baseline in MHD of moderate or severe intensity of ≥75% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Cumulative number of MHD of moderate to severe intensity From Day 1 to Week 24 The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.
Change from baseline in the number of days per month of acute migraine medication intake Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The acute migraine medication intake will be recorded in the daily eDiary Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan
Change from baseline in MMD of ≥50% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The monthly migraine days (MMD) is assessed by a daily eDiary.
Change from baseline in MMD of ≥75% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The monthly migraine days (MMD) is assessed by a daily eDiary.
Change from baseline in monthly headache days (MHD) of moderate or severe intensity Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Use of acute migraine medication (yes or no) Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The use of acute migraine medication will be recorded in the daily eDiary.
Change from baseline in role function restrictive domain of Migraine Specific Quality of Life Questionnaire (MSQ) At Week 12 and Week 24 The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Change from baseline in total MSQ score At Week 12 and Week 24 The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Change from baseline in MMD of moderate or severe intensity Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The intensity of MMD is assessed by a daily eDiary.
Change from baseline in MHD of moderate or severe intensity of ≥50% Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24) The intensity of monthly headache days (MHD) is assessed by a daily eDiary.
Patient's Global Impression of Change (PGIC) score At Week 12 and Week 24 The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
Change from baseline of ≥1 and ≥2 grades in PGIC score At Week 12 and Week 24 The PGIC will be assessed by a questionnaire (7-point scale, score of 1 indicates very much improved and score of 7 indicates very much worse)
Change in MSQ score to the minimally important difference/change (MID/MIC) At Week 12 and Week 24 The MSQ will be assessed by a questionnaire (Scores range from 0-100, higher scores indicate a better quality of life)
Change from baseline in total 6-item Headache Impact Test (HIT-6) score At Week 12 and Week 24 The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
Change in total 6-item Headache Impact Text (HIT-6) score to the minimally important difference/change (MID/MIC) At Week 12 and Week 24 The HIT-6 will be assessed by a questionnaire (scores range from 36-78 and higher scores indicate a greater impact of headache on subject's life)
Change from baseline in Short Form 12 (SF-12) Questionnaire score At Week 12 and Week 24 The SF-12 will be assessed by a questionnaire (scores range from 0-100, with higher scores indicating better functioning)
Treatment-emergence of suicidal ideation/suicidal behaviour From baseline up to Week 24 It will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) questionnaire that consists of 4 subscales:
1. Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe
2. Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.
3. Suicide behaviour subscale:4 types of suicidal behaviours are scored yes/no
4. Behaviour Lethality subscale: actual lethality/medical damage scores 0-5, with 5 being most severe (death) and potential lethality scores 0-2 with 2 being more potentially lethal.Change from baseline to Chronic migraine status At Week 24 (Week 21-24) Transition to Chronic migraine status will be assessed by the daily eDiary and defined as number of participants with ≥15 MHD and ≥8 MMD
Time to onset of effect From first time point post randomisation to Week 24 Time to onset of effect is defined as the first time point post randomisation where MMD is reduced from baseline ≥50%
Incidence of Treatment emergent adverse event (TEAEs) Up to Week 24 An Adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Percentage of Participants with clinically significant changes in vital signs From baseline up to Week 24 Percentage of participants with clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.
Percentage of participants with clinically significant laboratory parameters (blood chemistry, haematology) From baseline up to Week 24 Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will graded by the investigator.
Percentage of participants with Binding antibodies to Dysport® At Week 24 It will be assessed by collecting blood samples at baseline and Week 24. The determination of putative antibodies against BoNT-A will be evaluated using a validated method of electrochemiluminescence assays (ECLA) for the presence of binding antibodies to BoNT-A.
Percentage of participants with neutralising antibodies to Dysport® At Week 24 It will be performed only with confirmed positive samples in ECLA (confirmation of presence of binding antibodies) . The characterization of antibodies against BoNT-A will be evaluated using a validated method of cell-based assays (CBA) for the presence of neutralising antibodies to BoNT-A
Trial Locations
- Locations (108)
Hope Clinical Research, LLC
🇺🇸Canoga Park, California, United States
Axiom Research LLC
🇺🇸Colton, California, United States
Alliance Clinical San Diego (Acclaim Clinical Research)
🇺🇸San Diego, California, United States
Velocity Clinical Research - Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Clinical Neuroscience Solutions Healthcare, Inc (CNS Healthcare, INC)
🇺🇸Jacksonville, Florida, United States
Quantum Clinical Trials
🇺🇸Miami Beach, Florida, United States
Clinical Neuroscience Solutions, Inc ((CNS Healthcare) - Psychiatry)
🇺🇸Orlando, Florida, United States
Clinical Research of Central Florida (also known as Bon Clinic)
🇺🇸Winter Haven, Florida, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
M3 Wake Research - Las Vegas Wellness Way
🇺🇸Las Vegas, Nevada, United States
Scroll for more (98 remaining)Hope Clinical Research, LLC🇺🇸Canoga Park, California, United States