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Bisphosphonate

AXS-02 for Osteoarthritis (COAST-1 Trial)

Phase 3
Waitlist Available
Research Sponsored by Axsome Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12 and week 24
Awards & highlights

COAST-1 Trial 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.

Eligible Conditions
  • Osteoarthritis

COAST-1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12 and week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in patient reported pain intensity
Secondary outcome measures
Change in WOMAC pain and stiffness subscales over time
Clinical Global Impression of Change (CGI-C) scores
Patient Global Impression of Change (PGI-C)

COAST-1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-02Experimental Treatment1 Intervention
Administered orally in the morning for 6 weeks
Group II: PlaceboPlacebo Group1 Intervention
Administered orally in the morning for 6 weeks

Find a Location

Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor
28 Previous Clinical Trials
7,846 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
2016. "A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02746068.
~38 spots leftby Apr 2025
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