NCT02746068UnknownPhase 3
COAST -1: Clinical Knee Osteoarthritis Symptom Treatment 1 Study. A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of AXS-02 (Disodium Zoledronate Tetrahydrate) Administered Orally to Subjects With Knee Osteoarthritis Associated With Bone Marrow Lesions.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 346
- Locations
- 3
- Primary Endpoint
- Change in patient reported pain intensity
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- •Previous surgery on index knee
- •Any prior use of bisphosphonates within 6 months of screening
- •Additional criteria may apply
Arms & Interventions
AXS-02
Experimental
Administered orally in the morning for 6 weeks
Intervention: AXS-02 (Drug)
Placebo
Placebo Comparator
Administered orally in the morning for 6 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change in patient reported pain intensity
Time Frame: Baseline to Week 24
Patient reported pain intensity is recorded as an average daily pain intensity using an 11-point scale (0 = no pain to 10 = worst pain possible)
Secondary Outcomes
- Patient Global Impression of Change (PGI-C)(Week 12 and Week 24)
- Change in WOMAC pain and stiffness subscales over time(Baseline to Week 24)
- Clinical Global Impression of Change (CGI-C) scores(Week 12 and Week 24)
Investigators
Study Sites (3)
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