Complex Regional Pain SyndromePhase 3CREATE-1NCT02504008
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
A Phase 3 study testing AXS-02 (oral zoledronate) in people with Complex Regional Pain Syndrome and Reflex Sympathetic Dystrophy, run by Axsome Therapeutics, Inc. at 44 sites in 4 countries.
Trial summary
This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
- What is being tested?
- AXS-02 (oral zoledronate)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 44 sitesin 4 countries
- Study dates
- Jul 2015to Jan 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female of at least 18 years of age
- Recently confirmed diagnosis of CRPS-1 (Budapest criteria)
- Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10])
- Willing and able to provide written informed consent
Who cannot join
- Received chronic opioid therapy within 4 weeks
- Received a sympathetic nerve block within 3 weeks
- Active litigation or a pending workers' compensation decision
- Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States29 sites
Study site
Albuquerque, New Mexico
Study site
Bellevue, Washington
Study site
Canton, Georgia
Study site
Chicago, Illinois
Study site
Clermont, Florida
Study site
Dallas, Texas
Study site
Denver, Colorado
Study site
Encinitas, California
Study site
Hot Springs, Arkansas
Study site
La Jolla, California
Study site
Los Angeles, California
Study site
Louisville, Kentucky
Study site
Madison, Wisconsin
Study site
Marietta, Georgia
Study site
Meridian, Idaho
Study site
Miami, Florida
Study site
Napa, California
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Orlando, Florida, 32827
Study site
Portland, Oregon
Study site
San Antonio, Texas
Study site
Seattle, Washington
Study site
St. Marys, Georgia, 31558
Study site
Tampa, Florida
Study site
Temecula, California
Study site
Tucson, Arizona
Study site
West Palm Beach, Florida
Study site
Winston-Salem, North Carolina
United Kingdom8 sites
Study site
Darlington, County Durham
Study site
Glasgow
Study site
Lambeth, London
Study site
Liverpool, Merseyside
Study site
London
Study site
Newcastle upon Tyne, Tyne and Wear
Study site
Norwich, Norfolk
Study site
Warrington, Cheshire
Australia6 sites
Study site
Broadmeadow, New South Wales
Study site
Clayton, Victoria
Study site
Hurstville, New South Wales
Study site
Nedlands, Western Australia
Study site
Noosa, Queensland
Study site
Welland, South Australia
About this study
Official title: CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zoledronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)
This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I.
- Being tested
- AXS-02 (oral zoledronate), Placebo
- Keywords
- bisphosphonate, CRPS, RSD, non-opioid, CRPS-1, acute on chronic pain, chronic pain, zoledronic acid
- Medical subject headings
- Complex Regional Pain Syndromes, Reflex Sympathetic Dystrophy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXS-02 (oral zoledronate)Drug
Once weekly for 6 weeks
PlaceboDrug
Once weekly for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| AXS-02 (oral zoledronate) | Experimental | Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36 Receives: Drug: AXS-02 (oral zoledronate) |
| Placebo | Placebo comparator | Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36 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 12
Secondary outcomes (6)
Change in Brief Pain Inventory (BPI) Pain Score
The BPI is a nine-question survey completed by the patient that assesses quality of life and health status. BPI scores range from 0 to 10, with higher values indicating greater pain.
Measured: Baseline to Week 12
Patients' Global Impression of Change (PGI-C)
The PGI-C is a patient/patient's caregiver rated scale to assess the patients overall treatment response. PGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Measured: Baseline to Week 12
Clinicians' Global Impression of Change (CGI-C)
The CGI-C is an investigator-rated scale to assess the overall treatment response. CGI-C is a 7-point (1-7) scale rated as; very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Measured: Baseline to Week 12
Change in EuroQOL 5-dimensions questionnaire (EQ-5D)
The EQ-5D descriptive system comprised the following 5 dimensions: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by the patient at one of 5 levels, with level 1 indicating the best health state (no problems) and level 5 indicating worst health state (e.g., unable to walk about).
Measured: Baseline to Week 12
Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)
The SF-MPQ-2 measures both neuropathic and nonneuropathic pain. It contains a total of 22 descriptors, which are rated on an intensity scale of 0 = None, to 10 = Worst Possible.
Measured: Baseline to Week 12
Change in bone turnover markers
Bone turnover is measured from 2 biomarkers collected from peripheral blood samples: serum carboxy terminal telopeptide of collagen type I (CTX) and serum procollagen type I N terminal propeptide (s-P1NP).
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Regional Pain SyndromeStudies of the same condition, open and under way.
- 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
- 190 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
- NCT02504008
- Sponsor's protocol ID
- AXS02-301
- Acronym
- CREATE-1
- Status last verified
- Mar 2018
- First submitted
- 20 Jul 2015
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CREATE-1 Study: CRPS Treatment Evaluation 1 Study. A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of AXS-02 (Oral Zoledronate) Administered Orally to Subjects With Complex Regional Pain Syndrome Type I (CRPS-I)
- ClinicalTrials.gov ID
- NCT02504008
- Acronym / sponsor ID
- CREATE-1 / AXS02-301
- Keywords
- bisphosphonate, CRPS, RSD, non-opioid, CRPS-1, acute on chronic pain, chronic pain, zoledronic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Axsome Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 21 Jul 2015 (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 patients with CRPS-I.
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 (oral zoledronate) | Experimental | Drug: AXS-02 (oral zoledronate)Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36 |
| Placebo | Placebo comparator | Drug: PlaceboAdministered orally in the morning on Day 1, 8, 15, 22, 29, and 36 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female of at least 18 years of age
- Recently confirmed diagnosis of CRPS-1 (Budapest criteria)
- Average pain intensity score of ≥ 5 (based on an 11-point scale [0 - 10])
- Willing and able to provide written informed consent
Key exclusion criteria (4 listed)
- Received chronic opioid therapy within 4 weeks
- Received a sympathetic nerve block within 3 weeks
- Active litigation or a pending workers' compensation decision
- Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study
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 (oral zoledronate)Once weekly for 6 weeks | Drug | AXS-02 (oral zoledronate) |
| PlaceboOnce weekly for 6 weeks | Drug | Placebo |
Primary outcome
Change in patient reported pain intensity
Time frame: Baseline to Week 12
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).
6 secondary outcomes
Change in Brief Pain Inventory (BPI) Pain Score
Time frame: Baseline to Week 12
Patients' Global Impression of Change (PGI-C)
Time frame: Baseline to Week 12
Clinicians' Global Impression of Change (CGI-C)
Time frame: Baseline to Week 12
Change in EuroQOL 5-dimensions questionnaire (EQ-5D)
Time frame: Baseline to Week 12
Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)
Time frame: Baseline to Week 12
Change in bone turnover markers
Time frame: Baseline to Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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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.
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AXS-02 (oral zoledronate) in people with Complex Regional Pain Syndrome and Reflex Sympathetic Dystrophy, run by Axsome Therapeutics, Inc. at 44 sites in 4 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 4 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, United Kingdom, Australia, Canada. 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 12). 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 23 Mar 2018.