Recruiting NCT07616128
Study of EVO756 in Adults With Migraine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EVO756, Dose 1, EVO756, Dose 2, Placebo.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of EVO756 for the Prevention of Migraine in Adults
Overview
This study will evaluate the efficacy and safety of EVO756 against placebo in adults with migraine.
Interventions
- Drug EVO756, Dose 1
Orally administered EVO756, Dose 1 (Daily) - Drug EVO756, Dose 2
Orally administered EVO756, Dose 2 (Daily) - Drug Placebo
Placebo Control (Daily)
Primary outcome measures
- Mean change from baseline in the number of monthly migraine days (MMD) [Time frame: Last month of the 12-week treatment period]
Secondary outcome measures (6)
- Mean change from baseline in the number of MMD [Time frame: Weeks 4, 8, and across the treatment period (up to 12-weeks)]
- Mean change from baseline in the number of monthly headache days (MHD) [Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)]
- Proportion of subjects achieving ≥50% and ≥75% reduction in MMD [Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)]
- Proportion of subjects achieving ≥50% and ≥75% reduction in MHD [Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)]
- Mean change from baseline in monthly acute migraine medication use days [Time frame: Weeks 4, 8, 12, and across the treatment period (up to 12-weeks)]
- Occurrence of treatment emergent adverse events (TEAE) and serious adverse events (SAE) [Time frame: through Week 16]
Eligibility criteria
Inclusion criteria
- Adults aged 18 to <65 years
- Migraine with or without aura, per ICHD-3 criteria
- History of failure with prior preventive migraine treatments
- Not currently using migraine preventive therapy
Exclusion criteria
- Difficulty distinguishing migraine from other headache types or presence of other primary headache disorders
- Use of certain medications
- Any clinically significant medical, psychiatric, neurological, cardiovascular, or laboratory abnormalities
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 14 centers
- CA Medical Clinic for Headache — Los Angeles
- New England Institute for Neurology and Headache — Stamford
- Clinical Neuroscience Solutions, Inc. — Jacksonville
- Apple Medical Research Group, Inc — Miami
- Clinical Neuroscience Solutions, Inc. — Orlando
- Vantage Clinical Trials — Tampa
- Accel Research Site-Decatur-Alcanza — Decatur
- Michigan Headache and Neurological Institute — Ann Arbor
- … and 6 more centers
Identifiers
NCT: NCT07616128 · EVO756-MIG001