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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 : Recruiting
First Posted : April 21, 2016
Last Update Posted : August 28, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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 : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

  Show 58 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
First Posted: April 21, 2016    Key Record Dates
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