CRPS-RISE Outcomes Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAmbros Therapeutics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants from CRPS-RISE
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 .
Completed CRPS-RISE with a final trial visit at Week 6 (Visit 8) or later.
Completion of 4-infusions of neridronate 100 mg over approximately a 10-day period in CRPS-RISE.
Disqualifiers
None
Trial population
The registry target population for provisional enrollment includes all participants in CRPS-RISE, the parent trial of the Registry. After the completion of the last participant's last visit in CRPS-RISE and the unblinding of the trial, the Enrolled Study Cohort will be participants confirmed to have completed a four-infusion course of neridronate. The Enrolled Study Cohort will also include participants in the Open Label Extension study.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
270 Participants
are grouped into 2 trial groupsGroup A: Provisionally Enrolled Study Cohort
Group B: Enrolled Study Cohort
Trial outcomes
Primary outcomes
1
Change from baseline to each registry assessment of average pain in the past 24 hours.
Average pain (24-hour recall) reported on an 11-point numeric rating scale. This is recorded every 90 days from entry.
Time frame
Every 3 months from enrollment until up to 2 years after entry.2
Time to loss of benefit where benefit is 50% reduction in average pain intensity from baseline to Week 12 of the CRPS-RISE trial.
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.
Time frame
Every 3 months from enrollment until up to 2 years after entry.3
Change from baseline to each registry assessment in CRPS Severity Score Self-Report (CSS-SR) total score and individual items.
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.
Time frame
Every 3 months from entry to up to 24 months of participation.4
Change from baseline to each registry assessment in Patient Global Impression of Severity (PGI-S).
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.
Time frame
Every 3 months from enrollment until up to 2 years after entry.Other outcomes
1
Healthcare Use and Costs (Provisional)
The potential for inclusion of linked health care claims and electronic health record data will be enabled by having participants consent to tokenizing their identifying information.
Time frame
Every 3 months from enrollment until up to 2 years after entry.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov