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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

  Show 53 Study Locations
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 July 27, 2017