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Completed

NCT Number: NCT04163185

Initiating Early Control of Migraine Pain and Associated Symptoms

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AXS-07 (MoSEIC meloxicam and rizatriptan)

Drug

AXS-07 tablet taken once upon the earliest onset of migraine pain.

Placebo

Drug

Placebo tablet taken once upon the earliest onset of migraine pain.

Primary outcomes

  1. Percentage of Subjects Achieving Headache Pain Freedom at Hour 2

    Time frame: Hour 2

    Absence of headache pain at Hour 2

  2. Percentage of Subjects With Absence of Most Bothersome Symptom at Hour 2

    Time frame: Hour 2

    Absence of Most Bothersome Symptom, defined at the onset of migraine at Hour 2

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

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

Acronym: INTERCEPT

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2019
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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