Initiating Early Control of Migraine Pain and Associated Symptoms
Sponsored by Axsome Therapeutics, Inc.
About this trial
Last updated 4 years ago
Study ID
AXS-07-303
Status
Completed
Type
Interventional
Phase
Phase 3
Placebo
Yes
Accepting
18 to 65 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 5 years ago
What is this trial about?
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.
What are the Participation Requirements?
Key Inclusion Criteria:
• Has an established diagnosis of migraine with or without aura.
Key Exclusion Criteria:
- 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.