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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02746068




Registration number
NCT02746068
Ethics application status
Date submitted
14/04/2016
Date registered
21/04/2016
Date last updated
10/01/2019

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
Scientific 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.
Secondary ID [1] 0 0
AXS02-K301
Universal Trial Number (UTN)
Trial acronym
COAST-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis, Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AXS-02
Treatment: Drugs - Placebo

Experimental: AXS-02 - Administered orally in the morning for 6 weeks

Placebo Comparator: Placebo - Administered orally in the morning for 6 weeks


Treatment: Drugs: AXS-02


Treatment: Drugs: Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in patient reported pain intensity
Timepoint [1] 0 0
Baseline to Week 24
Secondary outcome [1] 0 0
Patient Global Impression of Change (PGI-C)
Timepoint [1] 0 0
Week 12 and Week 24
Secondary outcome [2] 0 0
Clinical Global Impression of Change (CGI-C) scores
Timepoint [2] 0 0
Week 12 and Week 24
Secondary outcome [3] 0 0
Change in WOMAC pain and stiffness subscales over time
Timepoint [3] 0 0
Baseline to Week 24

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous surgery on index knee

- Any prior use of bisphosphonates within 6 months of screening

- Additional criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2020
Actual
Sample size
Target
346
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Broadmeadow
Recruitment hospital [2] 0 0
- Noosa Heads
Recruitment hospital [3] 0 0
- Adelaide
Recruitment hospital [4] 0 0
- Hobart
Recruitment hospital [5] 0 0
- Clayton
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
4567 - Noosa Heads
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
7000 - Hobart
Recruitment postcode(s) [5] 0 0
3168 - Clayton
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Kansas
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Maryland
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Massachusetts
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Missouri
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New Mexico
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New York
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Virginia
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United States of America
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Washington

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Axsome Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02746068
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02746068