NCT00166452CompletedPhase 3
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
Study Overview
Brief Summary
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age > or = to 18 years
- •Signed consent form
- •A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
- •CRPS pain intensity score at least 4 on an 11-point PI-NRS
- •Measurable sural, median sensory, median motor and peroneal motor nerve conductions
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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