Clinical trial NCT02746068: A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Osteoarthritis, Knee
Keywords: Bone Marrow Lesions
AXS02
Axsome
Knee OA
Osteoarthritis
Lead sponsor: Axsome Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 346
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in patient reported pain intensity
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Week 12 and Week 24
measure: Clinical Global Impression of Change (CGI-C) scores
timeFrame: Week 12 and Week 24
measure: Change in WOMAC pain and stiffness subscales over time
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Achieve Clinical Research
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Hot Springs
country: United States
state: Arkansas
city: Anaheim
country: United States
state: California
city: Canoga Park
country: United States
state: California
city: El Cajon
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: North Hollywood
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Thousand Oaks
country: United States
state: California
city: Upland
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Milford
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Clermont
country: United States
state: Florida
city: Hialeah
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Lauderdale Lakes
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Port Orange
country: United States
facility: Accord Clinical Research
state: Florida
city: Port Saint Lucie
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Canton
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Oak Lawn
country: United States
facility: Affinity Clinical Research Institute
state: Illinois
city: Oak Lawn
country: United States
state: Illinois
city: Newton
country: United States
state: Kansas
city: Wheaton
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: North Attleboro
country: United States
state: Massachusetts
city: Quincy
country: United States
state: Massachusetts
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Hartsdale
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Charlotte
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Duncansville
country: United States
state: Pennsylvania
city: Mount Pleasant
country: United States
state: South Carolina
city: Franklin
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Baytown
country: United States
state: Texas
city: DeSoto
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Broadmeadow
country: Australia
state: New South Wales
city: Noosa Heads
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Hobart
country: Australia
state: Tasmania
city: Clayton
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
Study officials:
References: