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

Study acronym: E-BEOND
StatusActive, Not Recruiting
PhasePhase 3
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion date: Nov 6, 2026 to Nov 16, 2026v37
  2. Primary completion date changed from estimate of May 27, 2026 to Jun 1, 2026v36
  3. Re-verified, no change to tracked fieldsv35
  4. Primary completion date: Jun 5, 2026 to May 27, 2026 Completion date: Dec 4, 2026 to Nov 6, 2026v34 Show 1 more changeShow less
    • Completion date: Dec 4, 2026 to Nov 6, 2026
  5. Re-verified, no change to tracked fieldsv33
Show 31 earlier versionsHide 31 earlier versions
  1. Enrollment target: estimated 714 to confirmed 751 Primary completion date: Jun 22, 2026 to Jun 5, 2026 · Completion date: Dec 21, 2026 to Dec 4, 2026 · Eligibility criteria revised · 2 morev32 Show 5 more changesShow less
    • Primary completion date: Jun 22, 2026 to Jun 5, 2026
    • Completion date: Dec 21, 2026 to Dec 4, 2026
    • Eligibility criteria revised
    • Secondary endpoints: 27 to 30
    • Study sites revised (105)

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv31
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 110 to 105v30 Show 1 more changeShow less
    • Study sites: 110 to 105
  4. Study sites revised (110)v29 See this version in full on ClinicalTrials.gov ↗
  5. Site details revised at 2 of 110 sitesv28
  6. Study sites: 109 to 110v27
  7. Re-verified, no change to tracked fieldsv26
  8. Study sites: 93 to 109v25
  9. Site details revised at 7 of 93 sitesv24
  10. Study sites: 85 to 93v23
  11. Site details revised at 6 of 85 sitesv22
  12. Study sites: 82 to 85v21
  13. Study sites revised (82)v20 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 80 to 82v19
  15. Eligibility criteria expanded, about 80 wordsv18 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 74 to 80v17
  17. Study sites: 66 to 74 Eligibility criteria shortened, about 1 wordv16 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  18. 2 versions Re-verified since Aug 5, 2024, no change to tracked fieldsv14-v15
  19. Study sites: 65 to 66v13
  20. Re-verified, no change to tracked fieldsv12
  21. Primary completion date: Jul 31, 2025 to Jun 22, 2026 Study sites: 35 to 65 · Completion date: Dec 31, 2025 to Dec 21, 2026v11 Show 2 more changesShow less
    • Study sites: 35 to 65
    • Completion date: Dec 31, 2025 to Dec 21, 2026
  22. Study sites: 40 to 35v10
  23. Study sites: 26 to 40v9
  24. 2 versions Re-verified since Jan 30, 2024, no change to tracked fieldsv7-v8
  25. Study sites: 7 to 26 Primary completion date: Jan 26, 2026 to Jul 31, 2025 · Completion date: Jan 26, 2026 to Dec 31, 2025 · Interventions: Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Placebo (Other) to Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A…v6 Show 3 more changesShow less
    • Primary completion date: Jan 26, 2026 to Jul 31, 2025
    • Completion date: Jan 26, 2026 to Dec 31, 2025
    • Interventions: Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Dysport® (Biological), Placebo (Other) to Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A (Biological), Botulinum toxin type A…
  26. Re-verified, no change to tracked fieldsv5
  27. Site details revised at 3 of 7 sitesv4
  28. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jun 1, 2025 to Jan 26, 2026 · Study sites: 0 to 7 · Start date changed from estimate of Sep 2023 to Sep 29, 2023v3 Show 3 more changesShow less
    • Primary completion date: Jun 1, 2025 to Jan 26, 2026
    • Study sites: 0 to 7
    • Start date changed from estimate of Sep 2023 to Sep 29, 2023
  29. Secondary endpoints: 28 to 27v2 See this version in full on ClinicalTrials.gov ↗
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ipsen
46 trials monitored
See 4 trials at risk
Migraine
467 trials monitored
See 24 trials at risk
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).
Trial Details
NCT Number NCT06047457
Lead Sponsor Ipsen
Conditions Episodic Migraine
Enrollment 751 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov