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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AXS-02 (oral zoledronate) | Experimental | Administered orally in the morning on Days 1, 8, 15, 22, 29, and 36 |
|
| Placebo | Placebo Comparator | Administered orally in the morning on Day 1, 8, 15, 22, 29, and 36 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AXS-02 (oral zoledronate) | Drug | Once weekly for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Week 12 |
| Patients' Global Impression of Change (PGI-C) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
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| Placebo |
| Drug |
Once weekly for 6 weeks |
|
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. |
| 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. | 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). | 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. | 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). | Baseline to Week 52 |
| Hot Springs |
| Arkansas |
| United States |
| Encinitas | California | United States |
| La Jolla | California | United States |
| Los Angeles | California | United States |
| Napa | California | United States |
| Temecula | California | United States |
| Denver | Colorado | United States |
| Clermont | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | 32827 | United States |
| Tampa | Florida | United States |
| West Palm Beach | Florida | United States |
| Canton | Georgia | United States |
| Marietta | Georgia | United States |
| St. Marys | Georgia | 31558 | United States |
| Meridian | Idaho | United States |
| Chicago | Illinois | United States |
| Louisville | Kentucky | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Winston-Salem | North Carolina | United States |
| Oklahoma City | Oklahoma | United States |
| Portland | Oregon | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Bellevue | Washington | United States |
| Seattle | Washington | United States |
| Madison | Wisconsin | United States |
| Broadmeadow | New South Wales | Australia |
| Hurstville | New South Wales | Australia |
| Noosa | Queensland | Australia |
| Welland | South Australia | Australia |
| Clayton | Victoria | Australia |
| Nedlands | Western Australia | Australia |
| Sherbrooke | Quebec | Canada |
| Warrington | Cheshire | United Kingdom |
| Darlington | County Durham | United Kingdom |
| Lambeth | London | United Kingdom |
| Liverpool | Merseyside | United Kingdom |
| Norwich | Norfolk | United Kingdom |
| Newcastle upon Tyne | Tyne and Wear | United Kingdom |
| Glasgow | United Kingdom |
| London | United Kingdom |
| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D012019 | Reflex Sympathetic Dystrophy |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077211 | Zoledronic Acid |
| ID | Term |
|---|---|
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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