A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine
Recruiting
Phase 3
Interventional Study
Chronic Migraine
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 780 (estimated)
- Sponsor
- Merz Therapeutics GmbH · Industry
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About This Trial
In this clinical trial, participants with chronic migraine will receive injections with Xeomin or Placebo into muscles of the head and neck. The purpose is to measure the change in monthly migraine days with Xeomin injections compared to Placebo injections.
Trial details include:
* Trial duration: 52 to 55 weeks;
* Screening period: 4 to 5 weeks;
* Treatment duration: 4 treatments, each abo…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant has a diagnosis of CM with or without aura according to the International Classification of Headache Disorders Edition 3 criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches;
* Participant age \< 50 years at the t…
Contacts