CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
Unknown statusPhase 3NCT02504008
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Brief summary (from the registry)
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 details
- 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)
- Conditions
- Complex Regional Pain Syndrome
- Reflex Sympathetic Dystrophy
- Interventions
- Drug: AXS-02 (oral zoledronate)
- Drug: Placebo
- Sponsor
- Axsome Therapeutics, Inc.
- Start date
- 2015-07
- Primary completion
- 2019-01
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Australia, Canada, United Kingdom, United States
- Total sites listed
- 44
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Key Inclusion Criteria: * 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: * 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
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| Sherbrooke | Quebec |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02504008