Initiating Early Control of Migraine Pain and Associated Symptoms (INTERCEPT)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Migraine

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04163185

AXS-07-303

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 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.

Enrollment: 302 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.

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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302 participants in 2 patient groups, including a placebo group

AXS-07

Experimental group

Description:

Taken once upon migraine

Treatment:

Drug: AXS-07 (MoSEIC meloxicam and rizatriptan)

Placebo

Placebo Comparator group

Description:

Taken once upon migraine

Treatment:

Drug: Placebo