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

This study is currently recruiting participants.
Verified October 2016 by Axsome Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02746068
First Posted: April 21, 2016
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
  Purpose
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.

Condition Intervention Phase
Osteoarthritis, Knee Drug: AXS-02 Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Axsome Therapeutics, Inc.:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 346
Study Start Date: March 2016
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Kellie Kennon kkennon@axsome.com

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States, 35216
United States, Arizona
Recruiting
Chandler, Arizona, United States, 85224
Completed
Phoenix, Arizona, United States, 85023
United States, Arkansas
Recruiting
Hot Springs, Arkansas, United States, 71913
United States, California
Recruiting
Anaheim, California, United States, 92805
Recruiting
Canoga Park, California, United States, 91303
Recruiting
El Cajon, California, United States, 92020
Recruiting
La Mesa, California, United States, 91941
Recruiting
Long Beach, California, United States, 90806
Recruiting
Los Angeles, California, United States, 90036
Completed
North Hollywood, California, United States, 91606
Recruiting
Sacramento, California, United States, 95821
Recruiting
San Diego, California, United States, 92103
Recruiting
Thousand Oaks, California, United States, 91360
Recruiting
Upland, California, United States, 91786
United States, Colorado
Completed
Denver, Colorado, United States, 80230
United States, Connecticut
Recruiting
Milford, Connecticut, United States, 06460
United States, Florida
Recruiting
Boynton Beach, Florida, United States, 33472
Recruiting
Clearwater, Florida, United States, 33756
Recruiting
Clermont, Florida, United States, 34711
Recruiting
Hialeah, Florida, United States, 33012
Recruiting
Jupiter, Florida, United States, 33458
Recruiting
Lauderdale Lakes, Florida, United States, 33319
Recruiting
Orlando, Florida, United States, 32806
Not yet recruiting
Port Saint Lucie, Florida, United States, 34952
Recruiting
Sarasota, Florida, United States, 34232
United States, Georgia
Recruiting
Canton, Georgia, United States, 30114
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
Recruiting
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Recruiting
Newton, Kansas, United States, 67114
United States, Maryland
Recruiting
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States, 02111
Recruiting
North Attleboro, Massachusetts, United States, 02760
Completed
Quincy, Massachusetts, United States, 02169
United States, Missouri
Recruiting
Kansas City, Missouri, United States, 64114
Recruiting
Saint Louis, Missouri, United States, 63042
United States, New Mexico
Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Recruiting
Hartsdale, New York, United States, 10530
Completed
Rochester, New York, United States, 14618
United States, North Carolina
Completed
Charlotte, North Carolina, United States, 28204
Recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Completed
Cincinnati, Ohio, United States, 45227
United States, Pennsylvania
Completed
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Completed
Franklin, Tennessee, United States, 37067
United States, Texas
Completed
Austin, Texas, United States, 78745
Recruiting
Baytown, Texas, United States, 77521
Recruiting
DeSoto, Texas, United States, 75115
Recruiting
Wichita Falls, Texas, United States, 76309
United States, Virginia
Recruiting
Newport News, Virginia, United States, 23606
United States, Washington
Recruiting
Bellevue, Washington, United States, 98007
Australia, New South Wales
Recruiting
Broadmeadow, New South Wales, Australia, 2292
Australia, Queensland
Recruiting
Noosa Heads, Queensland, Australia, 4567
Australia, South Australia
Recruiting
Adelaide, South Australia, Australia, 5011
Australia, Tasmania
Recruiting
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Recruiting
Clayton, Victoria, Australia, 3168
Not yet recruiting
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Recruiting
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Axsome Therapeutics, Inc.
  More Information

Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02746068     History of Changes
Other Study ID Numbers: AXS02-K301
First Submitted: April 14, 2016
First Posted: April 21, 2016
Last Update Posted: August 28, 2017
Last Verified: October 2016

Keywords provided by Axsome Therapeutics, Inc.:
Bone Marrow Lesions
AXS02
Axsome
Knee OA
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases