Clinical trial NCT03896009: Maximizing Outcomes in Treating Acute Migraine
Official title: MOMENTUM: A Randomized, Double-blind, Single-dose, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
AXS-07
Meloxicam
Rizatriptan
Axsome
Axsome Therapeutics
MoSEIC meloxicam
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-29
Enrollment: 1594
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 meloxicam, rizatriptan, and placebo for the treatment of a migraine attack.

This is a randomized, double-blind, 4-arm, parallel group, single-dose, placebo-controlled trial. Subjects who successfully complete screening and continue to meet all entry criteria will be randomly assigned to take one dose of either AXS-07, meloxicam, rizatriptan, or placebo upon the occurrence of a qualifying migraine.


Eligibility criteria: Key Inclusion Criteria:

* Has an established diagnosis of migraine with or without aura.
* Has experienced an inadequate response to prior acute treatments.

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.

Primary outcomes:
measure: Percentage of Subjects Reporting Headache Pain Freedom
timeFrame: Hour 2 following dose administration
measure: Percentage of Subjects With Absence of Most Bothersome Symptom
timeFrame: Hour 2 following dose administration
Secondary outcomes:
Other outcomes:
Locations:
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city: Seattle
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Study officials:
References: