Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy
Conditions
Keywords
bisphosphonate, CRPS, RSD, non-opioid, CRPS-1, acute on chronic pain, chronic pain, zoledronic acid
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.
Interventions
DRUGAXS-02 (oral zoledronate)
Once weekly for 6 weeks
DRUGPlacebo
Once weekly for 6 weeks
Sponsors
Axsome Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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). |
| 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). |
Countries
Australia, Canada, United Kingdom, United States
Outcome results
None listed