Study Description

Study Design

Groups and Cohorts

Outcome Measures

Primary Outcome Measures

1. 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 eDiary, completed every day by the participant, to evaluate the efficacy of Dysport® compared to placebo.

Secondary Outcome Measures

1. 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.
2. 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.
3. Cumulative number of MMD [From Day 1 to Week 24]
   The cumulative number of monthly migraine days (MMD) is assessed by a daily eDiary.
4. 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.
5. 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.
6. 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.
7. 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.
8. Cumulative number of MHD of moderate or severe intensity [From Day 1 to Week 24]
   The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.
9. 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
10. 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)
11. 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.
12. Patient's Global Impression of Change (PGIC) score [At Weeek 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)
13. Change from baseline of ≥1 and ≥2 grades in PGIC score [At Weeek 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)
14. Change from baseline in role function restrictive domain of Migraine Specific Quality of Life (MSQ) Questionnaire [At Weeek 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)
15. Change from baseline in total MSQ score [At Weeek 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)
16. Change in MSQ score to the minimally important difference/change (MID/MIC) [At Weeek 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)
17. 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)
18. Change from baseline in HIT-6 score to MID/MIC [At Weeek 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)
19. Change from baseline in Short Form 12 (SF-12) Questionnaire score [At Weeek 12 and Week 24]
    The SF-12 will be assessed by a questionnaire (scores range from 0-100, with higher scores indicating better functioning)
20. Chronic migraine status [At Week 24 (Week 21-24)]
    Chronic migraine status will be assessed by the daily eDiary and defined as number of participants with ≥15 MHD and ≥8 MMD
21. 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%
22. 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.
23. 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.
24. 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.
25. 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:
    
    Ideation severity subscale: questions answered yes/no, severity of ideation scored 1-5 with 5 being most severe
    
    Intensity of ideation subscale : scores range from 2-25 with higher scores indicating more severe intensity of ideation.
    
    Suicide behaviour subscale:4 types of suicidal behaviours are scored yes/no
    
    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.
26. 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.
27. 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

Eligibility Criteria

Contacts and Locations

More Information

Additional Relevant MeSH Terms

• Migraine Disorders
• Headache Disorders, Primary
• Headache Disorders
• Brain Diseases
• Central Nervous System Diseases
• Nervous System Diseases