Episodic Migraine
Conditions
Brief summary
In this clinical trial, participants with episodic 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 about 12 weeks apart; and * Visit frequency: about every 4 weeks, 14 visits in total. The first and last visit and the 4 treatment visits are on-site, the other 8 visits are remote by phone / video call.
Interventions
DRUGXeomin
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
DRUGPlacebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl)
Sponsors
Merz Therapeutics GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant has a diagnosis of EM with or without aura according to current International Classification of Headache Disorders (Edition 3 and Edition 4 alpha) criteria for ≥ 12 months and is able to distinguish migraine headaches from all other types of headaches; * Participant age \< 50 years at the time of migraine onset; * Participant meeting the following headache and migraine day criteria in each of the 3 months prior to screening: history of ≤ 14 headache days per month and history of 6 to 14 migraine days per month; and * During the last 28 days of the screening period, participant experiencing: ≤ 14 headache days and 6 to 14 migraine days that qualify as such per the headache diary.
Exclusion criteria
* Diagnosis of chronic migraine; * Diagnosis of other primary headache types, except tension-type headache, which is permitted; * Diagnosis of aura without headache, migraine with brainstem aura, hemicrania continua, hypnic headache, hemiplegic migraine, retinal migraine, persistent aura without infarction, migraine aura-triggered seizure, or previous migrainous infarction; * Diagnosis of secondary headache types, except medication overuse headache, which is permitted; * Currently taking \> 1 prescribed drug for the preventive treatment of migraine; * Discontinuation of anti-calcitonin gene-related peptide (CGRP) / anti-CGRP receptor monoclonal antibody treatment less than 5 months prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A | Baseline to month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change in monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B | Baseline to month 6 |
| Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A | Baseline to month 6 |
| Change in monthly headache days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B | Baseline to month 6 |
| Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose A | Baseline to month 6 |
| Change in monthly acute migraine medication days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection) - Dose B | Baseline to month 6 |
| Change in frequency of migraine days from baseline (baseline monthly migraine days divided by 2) to two-week end-of-cycle periods (weeks 11 and 12 of Cycle 1 to 4) | Baseline up to 12 months |
| Percentage of participants who reported at least a 50% reduction in mean monthly migraine days from baseline (28 days before baseline visit) to Month 6 (weeks 21 to 24 after first injection | Baseline to month 6 |
| Incidence of treatment-emergent adverse events (TEAEs) related to treatment as assessed by the investigator in the placebo-controlled period | Month 6 |
Countries
Austria, Czechia, Denmark, France, Germany, Italy, Poland, Slovakia, Spain, United States
Contacts
CONTACTPublic Disclosure Manager
STUDY_DIRECTORMerz Medical Expert
Merz Therapeutics
Outcome results
None listed