A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Complex Regional Pain Syndrome, Type 1

Treatments: Drug: Lenalidamide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00166452

422-05

Details and patient eligibility

About

The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Age > or = to 18 years
2. Signed consent form
3. A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
4. CRPS pain intensity score at least 4 on an 11-point PI-NRS
5. Measurable sural, median sensory, median motor and peroneal motor nerve conductions
6. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind