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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

April 14, 2016
October 26, 2016
March 2016
September 2017   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT02746068 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Osteoarthritis, Knee
  • Drug: AXS-02
  • Drug: Placebo
  • Experimental: AXS-02
    Administered orally in the morning for 6 weeks
    Intervention: Drug: AXS-02
  • Placebo Comparator: Placebo
    Administered orally in the morning for 6 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
346
September 2017
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact: Kellie Kennon kkennon@axsome.com
United States,   Australia
 
 
NCT02746068
AXS02-K301
Yes
Not Provided
Not Provided
Not Provided
Axsome Therapeutics, Inc.
Axsome Therapeutics, Inc.
Not Provided
Not Provided
Axsome Therapeutics, Inc.
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP