A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions

Osteoarthritis, Knee Clinical Trial

— COAST-1  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02746068
• Other study ID #: AXS02-K301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: Axsome Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 346
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• AXS-02

• Placebo

Locations

Country	Name	City	State
United States	Achieve Clinical Research	Birmingham	Alabama
United States	Affinity Clinical Research Institute	Oak Lawn	Illinois
United States	Accord Clinical Research	Port Orange	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Axsome Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in patient reported pain intensity	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)	Baseline to Week 24
Secondary	Patient Global Impression of Change (PGI-C)		Week 12 and Week 24
Secondary	Clinical Global Impression of Change (CGI-C) scores		Week 12 and Week 24
Secondary	Change in WOMAC pain and stiffness subscales over time		Baseline to Week 24