A Phase 3 interventional study of AXS-02 (oral zoledronate) and Placebo in Complex Regional Pain Syndrome and Reflex Sympathetic Dystrophy, sponsored by Axsome Therapeutics, Inc.. Status unknown at 44 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by Axsome Therapeutics, Inc. · Phase 3, Interventional, and Treatment
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.
198 studies on the registry are indexed under Complex Regional Pain Syndromes; 55 are open to participants now.
This study's planned enrollment of 190 is above the median of 40 across 146 interventional studies indexed under Complex Regional Pain Syndromes.
Browse Complex Regional Pain Syndromes studies →Axsome Therapeutics, Inc. is the lead sponsor of 36 studies on the registry; 12 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 11 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36
Drug: AXS-02 (oral zoledronate)
Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36
Drug: Placebo
Once weekly for 6 weeks
Once weekly for 6 weeks
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).
Time frame: Baseline to Week 12
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: Baseline to Week 52
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Complex Regional Pain Syndromes→
Axsome Therapeutics, Inc.