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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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 - 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)
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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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
State/province [23] 0 0
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/show/NCT02746068
Trial related presentations / publications
Public notes

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

Summary results
Other publications