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Clinical trial

An Open-Label, Long-Term Study to Assess the Safety and Efficacy of AXS-07 (MoSEIC™ Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults

ID
Name
AXS-07-302
Description
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.
Trial arms
Trial start
2019-07-06
Estimated PCD
2020-09-22
Trial end
2020-09-22
Status
Completed
Phase
Early phase I
Treatment
AXS-07
AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
Arms:
AXS-07
Size
706
Primary endpoint
Long-term Safety of Chronic Intermittent Use of AXS-07
Up to 12 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 706, 'type': 'ACTUAL'}}
Updated at
2023-10-10

1 organization

1 product

1 indication

Organization
Axsome Therapeutics
Product
AXS-07
Indication
Migraine