A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions (COAST-1)

Axsome Therapeutics

Status and phase: Unknown; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Drug: AXS-02; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02746068

AXS02-K301

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in subjects with knee osteoarthritis associated with bone marrow lesions.

Enrollment: 346 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male at least 50 years of age, or postmenopausal female
• Meets the ACR clinical criteria for knee osteoarthritis
• Bone Marrow Lesion of the knee present on MRI
• Additional criteria may apply

Key Exclusion Criteria:

• Previous surgery on index knee
• Any prior use of bisphosphonates within 6 months of screening
• Additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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346 participants in 2 patient groups, including a placebo group

AXS-02

Experimental group

Description:

Administered orally in the morning for 6 weeks

Treatment:

Drug: AXS-02

Placebo

Placebo Comparator group

Description:

Administered orally in the morning for 6 weeks

Treatment:

Drug: Placebo