Complex Regional Pain Syndrome I (CRPS I)
Conditions
Keywords
CRPS 1, Reflex Sympathetic Dystrophy, RDS, CRPS, CRPS Type 1, Complex Regional Pain Syndrome Type 1
Brief summary
The goal of this observational study is to learn about how well neridronate keeps working in the months after treatment. For 12 or up to 24 months while the registry is open participants will answer online survey questions about their CRPS pain, medication use or procedures done and how CRPS affects what they are able to do.
Detailed description
The primary objective of the registry is to evaluate the long-term effectiveness of IV neridronate across three outcome domains in participants who qualified in CRPS-RISE with early, warm CRPS-1 and a positive triple phase bone scan, following prior treatment with four infusions of neridronate 100 mg IV over approximately a 10-day period. The three outcome domains include, patient report of health status, CRPS-1 related clinical events, and disability status. No neridronate treatment will be given as part of the registry and limited safety information will be collected. Participants will have received neridronate either through CRPS-RISE and/or through the Open Label Extension.
Interventions
None listed
Sponsors
Ambros Therapeutics, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants from CRPS-RISE 1. Completion of four infusions of IP (neridronate 100 mg over a \~ 10-day period \[or the renally modified dosing, as applicable\] or placebo) in CRPS-RISE . 2. Completed CRPS-RISE with a final trial visit at Week 6 (Visit 8) or later. Participants who meet both criteria will be provisionally enrolled pending post-trial unblinding and be included in the Provisionally Enrolled Study Cohort. After CRPS-RISE last patient last visit unblinding, only participants who meet the following neridronate exposure criterion #3 will continue in registry follow-up and be included in the Enrolled Study Cohort: 3. Completion of 4-infusions of neridronate 100 mg over approximately a 10-day period in CRPS-RISE. * Participants from the Open Label Extension (OLE) 1. Completion of 4 infusions of neridronate 100 mg over approximately a 10-day period (or the renally modified dosing, as applicable) in the OLE. 2. Completed OLE with a final trial visit at Week 6 (Visit 8) or later.
Exclusion criteria
There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to each registry assessment of average pain in the past 24 hours. | Every 3 months from enrollment until up to 2 years after entry. | Average pain (24-hour recall) reported on an 11-point numeric rating scale. This is recorded every 90 days from entry. |
| Time to loss of benefit where benefit is 50% reduction in average pain intensity from baseline to Week 12 of the CRPS-RISE trial. | Every 3 months from enrollment until up to 2 years after entry. | Each patient reported registry assessment of average pain in the past 24 hours will use an 11 point numeric rating scale. The analysis will be limited to participants who experienced benefit. Data will be summarized as Kaplan-Meier estimates. |
| Change from baseline to each registry assessment in CRPS Severity Score Self-Report (CSS-SR) total score and individual items. | Every 3 months from entry to up to 24 months of participation. | The CSS-SR is designed as a patient self-report questionnaire to assess the severity of CRPS signs and symptoms using plain language to assess 13 concepts. |
| Change from baseline to each registry assessment in Patient Global Impression of Severity (PGI-S). | Every 3 months from enrollment until up to 2 years after entry. | The 6-point PGI-S is an overall assessment of the participant's perception of the severity of their CRPS condition at the time of the assessment. Participants will respond to the question "How would you rate the symptoms of your CPRS at this time." Possible responses are scored from 0 to 5 representing none, minimal, mild, moderate, severe, very severe. |
| Change from baseline to each registry assessment in each of the Short Form 12 Health Survey (SF-12, Acute Version 2) domains, Physical Component Score (PCS), Mental Component Score (MCS), and individual items. | Every 3 months from enrollment until up to 2 years after entry. | The SF-12 is a widely used measure of general health status used in observational studies across a broad range of disease areas. It is a shortened version of the SF-36 V2.0 and yields 8 domain scores and a Physical Component Summary and Mental Component Summary. Each domain score is calculated by transforming raw responses to a 0-100 scale, where higher scores indicate better health status. |
| Change from baseline to each registry assessment in Daily Sleep Interference Scale (DSIS) in the past 24 hours on an 11-point numeric rating scale. | Every 3 months from enrollment until up to 2 years after entry. | The DSIS is a single-item scale that assesses "how much did your pain interfere with your sleep during the past 24 hours?" (0 = did not interfere; 10 = completely interfered |
| CRPS-1 Related Clinical Events during the 3 months preceding each registry assessment. | Every 3 months from enrollment until up to 2 years after entry. | The CRPS-1 Treatment Checklist was developed for this registry to assess commonly used pharmacologic treatments (e.g., opioids, neuropathic pain agents, ketamine, NSAIDs, bisphosphonates, corticosteroids, and topicals),interventional procedures (e.g., spinal cord or dorsal root ganglion stimulation, peripheral nerve stimulation, stellate/lumbar sympathetic blocks, sympathetic ablation/sympathectomy, intrathecal pump implant, and Bier block), and non-invasive rehabilitation therapies (e.g., physical therapy, occupational therapy, mirror visual feedback, psychological therapies, scrambler therapies or acupuncture). Participants select all CRPS-related treatments used in the past 3 months. The checklist will also record participation in the open-label clinical trial and is intended for descriptive evaluation of long-term CRPS-1 treatments with a focus on resource intensive events. The outcome domain assesses the long-term effectiveness of neridronate through patient reports. |
| Disability Status | Every 3 months from enrollment until up to 2 years after entry. | During the 3 months preceding each registry assessment the participant reported applying for or being on short-term disability, long-term disability, or workers compensation. As a binary endpoint, it will be summarized as frequencies and percentages. The domain assesses the long-term effectiveness of neridronate through patient reports of short-term disability, long-term disability, and workers compensation. |
Contacts
CONTACTCRPS-RiseRegistry
PRINCIPAL_INVESTIGATORJoel Castellanos, MD
UCSD
Outcome results
None listed