Initiating Early Control of Migraine Pain and Associated Symptoms
- Conditions
- Migraine
- Interventions
- Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)Drug: Placebo
- Registration Number
- NCT04163185
- Lead Sponsor
- Axsome Therapeutics, Inc.
- Brief Summary
AXS-07 is an oral, investigational medicine consisting of MoSEIC meloxicam and rizatriptan, which is being developed for the acute treatment of migraine with or without aura in adults. AXS-07 tablets are formulated to provide an enhanced rate of absorption of meloxicam. This study is designed to evaluate the efficacy and safety of AXS-07 compared to placebo.
This is a randomized, double-blind, single-dose, placebo-controlled trial. Subjects who successfully complete the screening period and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07 or placebo upon the earliest onset of migraine pain.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 302
• Has an established diagnosis of migraine with or without aura.
Key
- Has previously received any investigational drug or device or investigational therapy within 30 days before Screening.
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AXS-07 AXS-07 (MoSEIC meloxicam and rizatriptan) Taken once upon migraine Placebo Placebo Taken once upon migraine
- Primary Outcome Measures
Name Time Method Percentage of subjects reporting headache pain freedom Hour 2 Absence of headache pain
Percentage of subjects with absence of Most Bothersome Symptom Hour 2 Absence of Most Bothersome Symptom, defined at the onset of migraine
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Clinical Research Site
🇺🇸Charlottesville, Virginia, United States