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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)

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ClinicalTrials.gov Identifier: NCT02746068
Recruitment Status : Active, not recruiting
First Posted : April 21, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
Axsome Therapeutics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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



Primary Outcome Measures :
  1. 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 :
  1. Patient Global Impression of Change (PGI-C) [ Time Frame: Week 12 and Week 24 ]
  2. Clinical Global Impression of Change (CGI-C) scores [ Time Frame: Week 12 and Week 24 ]
  3. Change in WOMAC pain and stiffness subscales over time [ Time Frame: Baseline to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
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

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


  Hide Study Locations
Locations
United States, Alabama
Achieve Clinical Research
Birmingham, Alabama, United States, 35216
Birmingham, Alabama, United States, 35216
United States, Arizona
Chandler, Arizona, United States, 85224
Phoenix, Arizona, United States, 85023
United States, Arkansas
Hot Springs, Arkansas, United States, 71913
United States, 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
United States, Colorado
Denver, Colorado, United States, 80230
United States, Connecticut
Milford, Connecticut, United States, 06460
United States, 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
Accord Clinical Research
Port Orange, Florida, United States, 32129
Port Saint Lucie, Florida, United States, 34952
Sarasota, Florida, United States, 34232
United States, Georgia
Canton, Georgia, United States, 30114
United States, Illinois
Chicago, Illinois, United States, 60611
Affinity Clinical Research Institute
Oak Lawn, Illinois, United States, 60453
Oak Lawn, Illinois, United States, 60453
United States, Kansas
Newton, Kansas, United States, 67114
United States, Maryland
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Boston, Massachusetts, United States, 02111
North Attleboro, Massachusetts, United States, 02760
Quincy, Massachusetts, United States, 02169
United States, Missouri
Kansas City, Missouri, United States, 64114
Saint Louis, Missouri, United States, 63042
United States, New Mexico
Albuquerque, New Mexico, United States, 87106
United States, New York
Hartsdale, New York, United States, 10530
Rochester, New York, United States, 14618
United States, North Carolina
Charlotte, North Carolina, United States, 28204
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45227
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Franklin, Tennessee, United States, 37067
United States, Texas
Austin, Texas, United States, 78745
Baytown, Texas, United States, 77521
DeSoto, Texas, United States, 75115
Wichita Falls, Texas, United States, 76309
United States, Virginia
Newport News, Virginia, United States, 23606
United States, Washington
Bellevue, Washington, United States, 98007
Australia, New South Wales
Broadmeadow, New South Wales, Australia, 2292
Australia, Queensland
Noosa Heads, Queensland, Australia, 4567
Australia, South Australia
Adelaide, South Australia, Australia, 5011
Australia, Tasmania
Hobart, Tasmania, Australia, 7000
Australia, Victoria
Clayton, Victoria, Australia, 3168
Melbourne, Victoria, Australia, 3004
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Sponsors and Collaborators
Axsome Therapeutics, Inc.

Responsible Party: Axsome Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02746068     History of Changes
Other Study ID Numbers: AXS02-K301
First Posted: April 21, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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