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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. (see Contacts and Locations)
Verified October 2016 by Axsome Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02746068
First received: April 14, 2016
Last updated: October 26, 2016
Last verified: October 2016
  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 Blind (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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02746068

Contacts
Contact: Kellie Kennon kkennon@axsome.com

  Hide Study Locations
Locations
United States, Arizona
Not yet recruiting
Chandler, Arizona, United States, 85224
Recruiting
Phoenix, Arizona, United States, 85023
United States, Arkansas
Recruiting
Hot Springs, Arkansas, United States, 71913
United States, California
Recruiting
Anaheim, California, United States, 92805
Not yet 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
Not yet recruiting
Los Angeles, California, United States, 90036
Recruiting
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
Recruiting
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
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
Sarasota, Florida, United States, 34232
United States, Georgia
Recruiting
Canton, Georgia, United States, 30114
United States, Illinois
Recruiting
Chicago, Illinois, United States, 60611
United States, Kansas
Not yet 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
Recruiting
Quincy, Massachusetts, United States, 02169
United States, Missouri
Not yet recruiting
Kansas City, Missouri, United States, 64114
Not yet recruiting
St. 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
Recruiting
Rochester, New York, United States, 14618
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States, 28204
Not yet recruiting
Raleigh, North Carolina, United States, 27612
United States, Ohio
Recruiting
Cincinnati, Ohio, United States, 45227
United States, Pennsylvania
Recruiting
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Recruiting
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Not yet recruiting
Franklin, Tennessee, United States, 37067
United States, Texas
Recruiting
Austin, Texas, United States, 78745
Not yet recruiting
Baytown, Texas, United States, 77521
Not yet recruiting
DeSoto, Texas, United States, 75115
Recruiting
Wichita Falls, Texas, United States, 76309
United States, Virginia
Recruiting
Newport News, Virginia, United States, 23606
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
Study First Received: April 14, 2016
Last Updated: October 26, 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

ClinicalTrials.gov processed this record on April 24, 2017