NCT02504008UnknownPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Axsome Therapeutics, Inc.
- Enrollment
- 190
- Primary Endpoint
- Change in patient reported pain intensity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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
Arms & Interventions
AXS-02 (oral zoledronate)
Experimental
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Intervention: AXS-02 (oral zoledronate) (Drug)
Placebo
Placebo Comparator
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in Brief Pain Inventory (BPI) Pain Score(Baseline to Week 12)
- Patients' Global Impression of Change (PGI-C)(Baseline to Week 12)
- Clinicians' Global Impression of Change (CGI-C)(Baseline to Week 12)
- Change in EuroQOL 5-dimensions questionnaire (EQ-5D)(Baseline to Week 12)
- Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2)(Baseline to Week 12)
- Change in bone turnover markers(Baseline to Week 52)
Investigators
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