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NCT Number: NCT06047444

A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Chronic Migraine in Adults

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.

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 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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Migraine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centricity Research Halifax Multispecialty, Halifax, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Participant must have previously used, or is currently using, preventive treatment for migraine (pharmacological) (i.e. non-naïve) prior to start of screening eDiary

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 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 but limited to no more than 6 days per month (i.e 6 days per each 4-week period with gepant intake))
  • 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
  • Known history of treatment failure to more than four medications prescribed for the prevention of migraine (two of which have different mechanisms of action) or known history of treatment failure to botulinum toxin prescribed for the prevention of migraine.

Treatment and study plan

Botulinum toxin type A

Biological

Dose "A" Unit/Injection (U/I), Intramuscular (IM) on every 12 weeks during a period of 36 weeks with a total of 4 injections.

Other names: Dysport®

Placebo

Other

"0" U/I, IM on Day 1 and Week 12 with a total of 2 injections.

Primary outcomes

  1. Change from baseline at week 24 in monthly migraine days (MMD)

    Time frame: 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 outcomes

  1. Change from baseline in MMD of ≥50%

    Time frame: 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%

    Time frame: 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

    Time frame: 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

    Time frame: 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 the number of MMD over the last 12 weeks prior to Week 24

    Time frame: From Week 13 - 24

    The monthly migraine days (MMD) is assessed by a daily eDiary.

  6. Change from baseline in monthly headache days (MHD) of moderate or severe intensity

    Time frame: 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 ≥50%

    Time frame: 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. Change from baseline in MHD of moderate or severe intensity of ≥75%

    Time frame: 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.

  9. Cumulative number of MHD of moderate or severe intensity

    Time frame: From Day 1 to Week 24

    The cumulative number of monthly headache days (MHD) is assessed by a daily eDiary.

  10. Change from baseline in the number of days per month of acute migraine medication intake

    Time frame: Every 4 weeks from Week 4 (Weeks 1-4) to Week 24 (Weeks 21-24)

    The acute migraine specific medication intake will be recorded in the daily eDiary. Acute migraine medication is defined as triptan, ergotamine, gepant, or ditan.

  11. Headache medication overuser (yes, no)

    Time frame: 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)

  12. Use of acute migraine medication (yes or no)

    Time frame: 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.

  13. Patient's Global Impression of Change (PGIC) score

    Time frame: 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 of ≥1 and ≥2 grades in PGIC score

    Time frame: 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)

  15. Change from baseline in role function restrictive (RFR) domain of Migraine Specific Quality of Life (MSQ) Questionnaire

    Time frame: 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 from baseline in role function-preventive (RFP) domain of MSQ Questionnaire

    Time frame: 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)

  17. Change from baseline in emotional function (EF) domain of MSQ Questionnaire

    Time frame: 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)

  18. Change from baseline in total MSQ score

    Time frame: 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)

  19. Change in MSQ score to the minimally important change (MIC) thresholds

    Time frame: 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)

  20. Change from baseline in total 6-item Headache Impact Test (HIT-6) score

    Time frame: 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)

  21. Change from baseline in HIT-6 score to MIC thresholds

    Time frame: 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)

  22. Change from baseline in Short Form 12 (SF-12) Questionnaire score

    Time frame: 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)

  23. Chronic migraine status

    Time frame: 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

  24. Time to onset of effect

    Time frame: 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%

  25. Incidence of Treatment emergent adverse event (TEAEs)

    Time frame: 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.

  26. Percentage of Participants with clinically significant changes in vital signs

    Time frame: 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.

  27. Percentage of participants with clinically significant laboratory parameters (blood chemistry, haematology)

    Time frame: 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.

  28. Treatment-emergence of suicidal ideation/suicidal behaviour

    Time frame: 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.

  29. Percentage of participants with binding antibodies to Dysport®

    Time frame: At Week 24

    Presence of binding antibodies will be assessed using a validated method of electrochemiluminescence assay (ECLA).

  30. Percentage of participants with neutralising antibodies to Dysport®

    Time frame: At Week 24

    It will be performed only for confirmed positive samples with ECLA (confirmation of the presence of binding antibodies). Presence of neutralizing antibodies will be assessed using a validated cell-based assay (CBA).

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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 Chronic Migraine in Adult Participants

Acronym: C-BEOND

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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