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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)

Primary Purpose

Osteoarthritis, Knee

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AXS-02
Placebo
Sponsored by
Axsome Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Bone Marrow Lesions, AXS02, Axsome, Knee OA, Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Achieve Clinical Research
  • Accord Clinical Research
  • Affinity Clinical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AXS-02

Placebo

Arm Description

Administered orally in the morning for 6 weeks

Administered orally in the morning for 6 weeks

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Patient Global Impression of Change (PGI-C)
Clinical Global Impression of Change (CGI-C) scores
Change in WOMAC pain and stiffness subscales over time

Full Information

First Posted
April 14, 2016
Last Updated
January 8, 2019
Sponsor
Axsome Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02746068
Brief Title
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Axsome Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Bone Marrow Lesions, AXS02, Axsome, Knee OA, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
346 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AXS-02
Arm Type
Experimental
Arm Description
Administered orally in the morning for 6 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Administered orally in the morning for 6 weeks
Intervention Type
Drug
Intervention Name(s)
AXS-02
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in patient reported pain intensity
Description
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)
Time Frame
Baseline to Week 24
Secondary Outcome Measure Information:
Title
Patient Global Impression of Change (PGI-C)
Time Frame
Week 12 and Week 24
Title
Clinical Global Impression of Change (CGI-C) scores
Time Frame
Week 12 and Week 24
Title
Change in WOMAC pain and stiffness subscales over time
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Achieve Clinical Research
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91941
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Accord Clinical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
City
Canton
State/Province
Georgia
ZIP/Postal Code
30114
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Affinity Clinical Research Institute
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63042
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
City
Noosa Heads
State/Province
Queensland
ZIP/Postal Code
4567
Country
Australia
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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