A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions (COAST-1)
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ClinicalTrials.gov Identifier: NCT02746068 |
Recruitment Status : Unknown
Verified January 2019 by Axsome Therapeutics, Inc..
Recruitment status was: Active, not recruiting
First Posted : April 21, 2016
Last Update Posted : January 10, 2019
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Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis, Knee | Drug: AXS-02 Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 346 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Study Start Date : | March 2016 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: AXS-02
Administered orally in the morning for 6 weeks
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Drug: AXS-02 |
Placebo Comparator: Placebo
Administered orally in the morning for 6 weeks
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Drug: Placebo |
- 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)
- Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 and Week 24 ]
- Clinical Global Impression of Change (CGI-C) scores [ Time Frame: Week 12 and Week 24 ]
- Change in WOMAC pain and stiffness subscales over time [ Time Frame: Baseline to Week 24 ]

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02746068

Responsible Party: | Axsome Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02746068 |
Other Study ID Numbers: |
AXS02-K301 |
First Posted: | April 21, 2016 Key Record Dates |
Last Update Posted: | January 10, 2019 |
Last Verified: | January 2019 |
Bone Marrow Lesions AXS02 Axsome Knee OA Osteoarthritis |
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |