COAST-1: A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions

Sponsor

Axsome Therapeutics, Inc. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02746068

Collaborator

(none)

346

Enrollment

Locations

Arms

Duration (Months)

5.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Mar 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

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

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

Change in patient reported pain intensity [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) [Week 12 and Week 24]
Clinical Global Impression of Change (CGI-C) scores [Week 12 and Week 24]
Change in WOMAC pain and stiffness subscales over time [Baseline to Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Achieve Clinical Research	Birmingham	Alabama	United States	35216
2		Birmingham	Alabama	United States	35216
3		Chandler	Arizona	United States	85224
4		Phoenix	Arizona	United States	85023
5		Hot Springs	Arkansas	United States	71913
6		Anaheim	California	United States	92805
7		Canoga Park	California	United States	91303
8		El Cajon	California	United States	92020
9		La Mesa	California	United States	91941
10		Long Beach	California	United States	90806
11		Los Angeles	California	United States	90036
12		North Hollywood	California	United States	91606
13		Sacramento	California	United States	95821
14		San Diego	California	United States	92103
15		Thousand Oaks	California	United States	91360
16		Upland	California	United States	91786
17		Denver	Colorado	United States	80230
18		Milford	Connecticut	United States	06460
19		Boynton Beach	Florida	United States	33472
20		Clearwater	Florida	United States	33756
21		Clermont	Florida	United States	34711
22		Hialeah	Florida	United States	33012
23		Jupiter	Florida	United States	33458
24		Lauderdale Lakes	Florida	United States	33319
25		Orlando	Florida	United States	32806
26	Accord Clinical Research	Port Orange	Florida	United States	32129
27		Port Saint Lucie	Florida	United States	34952
28		Sarasota	Florida	United States	34232
29		Canton	Georgia	United States	30114
30		Chicago	Illinois	United States	60611
31	Affinity Clinical Research Institute	Oak Lawn	Illinois	United States	60453
32		Oak Lawn	Illinois	United States	60453
33		Newton	Kansas	United States	67114
34		Wheaton	Maryland	United States	20902
35		Boston	Massachusetts	United States	02111
36		North Attleboro	Massachusetts	United States	02760
37		Quincy	Massachusetts	United States	02169
38		Kansas City	Missouri	United States	64114
39		Saint Louis	Missouri	United States	63042
40		Albuquerque	New Mexico	United States	87106
41		Hartsdale	New York	United States	10530
42		Rochester	New York	United States	14618
43		Charlotte	North Carolina	United States	28204
44		Raleigh	North Carolina	United States	27612
45		Cincinnati	Ohio	United States	45227
46		Duncansville	Pennsylvania	United States	16635
47		Mount Pleasant	South Carolina	United States	29464
48		Franklin	Tennessee	United States	37067
49		Austin	Texas	United States	78745
50		Baytown	Texas	United States	77521
51		DeSoto	Texas	United States	75115
52		Wichita Falls	Texas	United States	76309
53		Newport News	Virginia	United States	23606
54		Bellevue	Washington	United States	98007
55		Broadmeadow	New South Wales	Australia	2292
56		Noosa Heads	Queensland	Australia	4567
57		Adelaide	South Australia	Australia	5011
58		Hobart	Tasmania	Australia	7000
59		Clayton	Victoria	Australia	3168
60		Melbourne	Victoria	Australia	3004
61		Nedlands	Western Australia	Australia	6009