Maximizing Outcomes in Treating Acute Migraine (MOMENTUM)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: Rizatriptan; Drug: AXS-07 (MoSEIC meloxicam and rizatriptan); Drug: Meloxicam; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03896009

AXS-07-301

Details and patient eligibility

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 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.

Enrollment: 1,594 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,594 participants in 4 patient groups, including a placebo group

AXS-07

Experimental group

Description:

Taken once upon a qualifying migraine

Treatment:

Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)

Meloxicam

Active Comparator group

Description:

Taken once upon a qualifying migraine

Treatment:

Drug: Meloxicam

Rizatriptan

Active Comparator group

Description:

Taken once upon a qualifying migraine

Treatment:

Drug: Rizatriptan

Placebo

Placebo Comparator group

Description:

Taken once upon a qualifying migraine

Treatment:

Drug: Placebo