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Not listed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT02746068

Public ClinicalTrials.gov record NCT02746068. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 1, 2026, 6:25 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT02746068
Recruitment status
Not listed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Axsome Therapeutics, Inc.
Industry
Enrollment
346 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
50 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 29, 2016
Primary completion
Nov 30, 2020
Completion
Nov 30, 2020
Last update posted
Jan 9, 2019

2016 – 2020

United States locations

U.S. sites
54
U.S. states
23
U.S. cities
52
Facility City State ZIP Site status
Achieve Clinical Research Birmingham Alabama 35216
Not listed Birmingham Alabama 35216
Not listed Chandler Arizona 85224
Not listed Phoenix Arizona 85023
Not listed Hot Springs Arkansas 71913
Not listed Anaheim California 92805
Not listed Canoga Park California 91303
Not listed El Cajon California 92020
Not listed La Mesa California 91941
Not listed Long Beach California 90806
Not listed Los Angeles California 90036
Not listed North Hollywood California 91606
Not listed Sacramento California 95821
Not listed San Diego California 92103
Not listed Thousand Oaks California 91360
Not listed Upland California 91786
Not listed Denver Colorado 80230
Not listed Milford Connecticut 06460
Not listed Boynton Beach Florida 33472
Not listed Clearwater Florida 33756
Not listed Clermont Florida 34711
Not listed Hialeah Florida 33012
Not listed Jupiter Florida 33458
Not listed Lauderdale Lakes Florida 33319
Not listed Orlando Florida 32806
Accord Clinical Research Port Orange Florida 32129
Not listed Port Saint Lucie Florida 34952
Not listed Sarasota Florida 34232
Not listed Canton Georgia 30114
Not listed Chicago Illinois 60611
Affinity Clinical Research Institute Oak Lawn Illinois 60453
Not listed Oak Lawn Illinois 60453
Not listed Newton Kansas 67114
Not listed Wheaton Maryland 20902
Not listed Boston Massachusetts 02111
Not listed North Attleboro Massachusetts 02760
Not listed Quincy Massachusetts 02169
Not listed Kansas City Missouri 64114
Not listed St Louis Missouri 63042
Not listed Albuquerque New Mexico 87106
Not listed Hartsdale New York 10530
Not listed Rochester New York 14618
Not listed Charlotte North Carolina 28204
Not listed Raleigh North Carolina 27612
Not listed Cincinnati Ohio 45227
Not listed Duncansville Pennsylvania 16635
Not listed Mt. Pleasant South Carolina 29464
Not listed Franklin Tennessee 37067
Not listed Austin Texas 78745
Not listed Baytown Texas 77521
Not listed DeSoto Texas 75115
Not listed Wichita Falls Texas 76309
Not listed Newport News Virginia 23606
Not listed Bellevue Washington 98007

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02746068, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 9, 2019 · Synced Sep 1, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02746068 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →