Osteoarthritis, KneePhase 3COAST-1NCT02746068
A Study to Assess the Efficacy and Safety of AXS-02 in Subjects With Knee OA Associated With Bone Marrow Lesions
A Phase 3 study testing AXS-02 in people with Osteoarthritis, Knee, run by Axsome Therapeutics, Inc. at 61 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- AXS-02
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 346 participants
- Where
- 61 sitesin 2 countries
- Study dates
- Mar 2016to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous surgery on index knee
- Any prior use of bisphosphonates within 6 months of screening
- Additional criteria may apply
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States54 sites
Study site
Albuquerque, New Mexico, 87106
Study site
Anaheim, California, 92805
Study site
Austin, Texas, 78745
Study site
Baytown, Texas, 77521
Study site
Bellevue, Washington, 98007
Achieve Clinical Research
Birmingham, Alabama, 35216
Study site
Birmingham, Alabama, 35216
Study site
Boston, Massachusetts, 02111
Study site
Boynton Beach, Florida, 33472
Study site
Canoga Park, California, 91303
Study site
Canton, Georgia, 30114
Study site
Chandler, Arizona, 85224
Study site
Charlotte, North Carolina, 28204
Study site
Chicago, Illinois, 60611
Study site
Cincinnati, Ohio, 45227
Study site
Clearwater, Florida, 33756
Study site
Clermont, Florida, 34711
Study site
Denver, Colorado, 80230
Study site
DeSoto, Texas, 75115
Study site
Duncansville, Pennsylvania, 16635
Study site
El Cajon, California, 92020
Study site
Franklin, Tennessee, 37067
Study site
Hartsdale, New York, 10530
Study site
Hialeah, Florida, 33012
Study site
Hot Springs, Arkansas, 71913
Study site
Jupiter, Florida, 33458
Study site
Kansas City, Missouri, 64114
Study site
La Mesa, California, 91941
Study site
Lauderdale Lakes, Florida, 33319
Study site
Long Beach, California, 90806
Study site
Los Angeles, California, 90036
Study site
Milford, Connecticut, 06460
Study site
Mt. Pleasant, South Carolina, 29464
Study site
Newport News, Virginia, 23606
Study site
Newton, Kansas, 67114
Study site
North Attleboro, Massachusetts, 02760
Study site
North Hollywood, California, 91606
Affinity Clinical Research Institute
Oak Lawn, Illinois, 60453
Study site
Oak Lawn, Illinois, 60453
Study site
Orlando, Florida, 32806
Study site
Phoenix, Arizona, 85023
Accord Clinical Research
Port Orange, Florida, 32129
Study site
Port Saint Lucie, Florida, 34952
Study site
Quincy, Massachusetts, 02169
Study site
Raleigh, North Carolina, 27612
Study site
Rochester, New York, 14618
Study site
Sacramento, California, 95821
Study site
San Diego, California, 92103
Study site
Sarasota, Florida, 34232
Study site
St Louis, Missouri, 63042
Study site
Thousand Oaks, California, 91360
Study site
Upland, California, 91786
Study site
Wheaton, Maryland, 20902
Study site
Wichita Falls, Texas, 76309
Australia7 sites
Study site
Adelaide, South Australia, 5011
Study site
Broadmeadow, New South Wales, 2292
Study site
Clayton, Victoria, 3168
Study site
Hobart, Tasmania, 7000
Study site
Melbourne, Victoria, 3004
Study site
Nedlands, Western Australia, 6009
Study site
Noosa, Queensland, 4567
About this study
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.
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- AXS-02, Placebo
- Keywords
- Bone Marrow Lesions, AXS02, Axsome, Knee OA, Osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-02Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AXS-02 | Experimental | Administered orally in the morning for 6 weeks Receives: Drug: AXS-02 |
| Placebo | Placebo comparator | Administered orally in the morning for 6 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Week 24
Secondary outcomes (3)
Patient Global Impression of Change (PGI-C)
Measured: Week 12 and Week 24
Clinical Global Impression of Change (CGI-C) scores
Measured: Week 12 and Week 24
Change in WOMAC pain and stiffness subscales over time
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Axsome Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Axsome Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02746068
- Sponsor's protocol ID
- AXS02-K301
- Acronym
- COAST-1
- Status last verified
- Jan 2019
- First submitted
- 14 Apr 2016
- Last updated
- 10 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02746068
- Acronym / sponsor ID
- COAST-1 / AXS02-K301
- Conditions
- Osteoarthritis, Knee
- Keywords
- Bone Marrow Lesions, AXS02, Axsome, Knee OA, Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 21 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AXS-02 | Experimental | Drug: AXS-02Administered orally in the morning for 6 weeks |
| Placebo | Placebo comparator | Drug: PlaceboAdministered orally in the morning for 6 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (3 listed)
- Previous surgery on index knee
- Any prior use of bisphosphonates within 6 months of screening
- Additional criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AXS-02 | Drug | AXS-02 |
| Placebo | Drug | Placebo |
Primary outcome
Change in patient reported pain intensity
Time frame: 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)
3 secondary outcomes
Patient Global Impression of Change (PGI-C)
Time frame: Week 12 and Week 24
Clinical Global Impression of Change (CGI-C) scores
Time frame: Week 12 and Week 24
Change in WOMAC pain and stiffness subscales over time
Time frame: Baseline to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
61 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-02 in people with Osteoarthritis, Knee, run by Axsome Therapeutics, Inc. at 61 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient reported pain intensity (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2019.