CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1
- Conditions
- Reflex Sympathetic DystrophyComplex Regional Pain Syndrome
- Interventions
- Drug: AXS-02 (oral zoledronate)Drug: Placebo
- Registration Number
- NCT02504008
- Lead Sponsor
- Axsome Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 190
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AXS-02 (oral zoledronate) AXS-02 (oral zoledronate) Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36 Placebo Placebo Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
- Primary Outcome Measures
Name Time Method Change in patient reported pain intensity 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 Outcome Measures
Name Time Method Change in Brief Pain Inventory (BPI) Pain Score Baseline to Week 12 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.
Patients' Global Impression of Change (PGI-C) Baseline to Week 12 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.
Clinicians' Global Impression of Change (CGI-C) Baseline to Week 12 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.
Change in EuroQOL 5-dimensions questionnaire (EQ-5D) Baseline to Week 12 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).
Change in Short-Form McGill Pain Questionnaire (SF-MPQ-2) Baseline to Week 12 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.
Change in bone turnover markers Baseline to Week 52 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).