Trials / Unknown
UnknownNCT02746068
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
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.
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 346 (estimated)
- Sponsor
- Axsome Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AXS-02 | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2016-04-21
- Last updated
- 2019-01-10
Locations
61 sites across 2 countries: United States, Australia
Source: ClinicalTrials.gov record NCT02746068. Inclusion in this directory is not an endorsement.