Multimechanistic Treatment Over Time of Migraine Symptoms (MOVEMENT)

Axsome Therapeutics

Status and phase: Completed; Phase 3

Conditions: Migraine

Treatments: Drug: AXS-07

Study type: Interventional

Funder types: Industry

Identifiers

NCT04068051

AXS-07-302

Details and patient eligibility

About

MOVEMENT (Multimechanistic Treatment over Time of Migraine Symptoms) is a Phase 3 study to evaluate the long-term safety of chronic intermittent use of AXS-07 and to assess the effect of AXS-07 on migraine symptoms following repeated treatment of migraine attacks.

Full description

This study is a Phase 3, multicenter, open-label, trial to evaluate the long-term safety and efficacy of intermittent chronic dosing with AXS-07 in subjects with migraine attacks. Eligible subjects will take AXS-07 following the onset of a migraine. Subjects will be treated for up to 12 months.

Enrollment: 706 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has participated in a prior study with AXS-07 for the treatment of migraine

Exclusion criteria

• Has previously received any investigational drug or device or investigational therapy within 30 days before Screening, other than AXS-07
• Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

706 participants in 1 patient group

AXS-07

Experimental group

Treatment:

Drug: AXS-07