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.

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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: August 24, 2017

Last verified: October 2016

History of Changes

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 (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:

MedlinePlus related topics: Osteoarthritis

U.S. FDA Resources

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 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
Study First Received:	April 14, 2016
Last Updated:	August 24, 2017

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 September 21, 2017

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