A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions (COAST-1)

January 8, 2019 updated by: Axsome Therapeutics, Inc.

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.

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

346

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
    • Queensland
      • Noosa Heads, Queensland, Australia, 4567
    • South Australia
      • Adelaide, South Australia, Australia, 5011
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35216
        • Achieve Clinical Research
      • Birmingham, Alabama, United States, 35216
    • Arizona
      • Chandler, Arizona, United States, 85224
      • Phoenix, Arizona, United States, 85023
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
    • California
      • Anaheim, California, United States, 92805
      • Canoga Park, California, United States, 91303
      • El Cajon, California, United States, 92020
      • La Mesa, California, United States, 91941
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90036
      • North Hollywood, California, United States, 91606
      • Sacramento, California, United States, 95821
      • San Diego, California, United States, 92103
      • Thousand Oaks, California, United States, 91360
      • Upland, California, United States, 91786
    • Colorado
      • Denver, Colorado, United States, 80230
    • Connecticut
      • Milford, Connecticut, United States, 06460
    • Florida
      • Boynton Beach, Florida, United States, 33472
      • Clearwater, Florida, United States, 33756
      • Clermont, Florida, United States, 34711
      • Hialeah, Florida, United States, 33012
      • Jupiter, Florida, United States, 33458
      • Lauderdale Lakes, Florida, United States, 33319
      • Orlando, Florida, United States, 32806
      • Port Orange, Florida, United States, 32129
        • Accord Clinical Research
      • Port Saint Lucie, Florida, United States, 34952
      • Sarasota, Florida, United States, 34232
    • Georgia
      • Canton, Georgia, United States, 30114
    • Illinois
      • Chicago, Illinois, United States, 60611
      • Oak Lawn, Illinois, United States, 60453
        • Affinity Clinical Research Institute
      • Oak Lawn, Illinois, United States, 60453
    • Kansas
      • Newton, Kansas, United States, 67114
    • Maryland
      • Wheaton, Maryland, United States, 20902
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • North Attleboro, Massachusetts, United States, 02760
      • Quincy, Massachusetts, United States, 02169
    • Missouri
      • Kansas City, Missouri, United States, 64114
      • Saint Louis, Missouri, United States, 63042
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Hartsdale, New York, United States, 10530
      • Rochester, New York, United States, 14618
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
      • Raleigh, North Carolina, United States, 27612
    • Ohio
      • Cincinnati, Ohio, United States, 45227
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Franklin, Tennessee, United States, 37067
    • Texas
      • Austin, Texas, United States, 78745
      • Baytown, Texas, United States, 77521
      • DeSoto, Texas, United States, 75115
      • Wichita Falls, Texas, United States, 76309
    • Virginia
      • Newport News, Virginia, United States, 23606
    • Washington
      • Bellevue, Washington, United States, 98007

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AXS-02
Administered orally in the morning for 6 weeks
Drug: AXS-02
Placebo Comparator: Placebo
Administered orally in the morning for 6 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Global Impression of Change (PGI-C)
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Clinical Global Impression of Change (CGI-C) scores
Time Frame: Week 12 and Week 24
Week 12 and Week 24
Change in WOMAC pain and stiffness subscales over time
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Axsome Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

April 18, 2016

First Posted (Estimate)

April 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXS02-K301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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