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

Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00166452

Enrollment

Registered

2005-09-14

Start date

2005-07-31

Completion date

2009-02-28

Last updated

2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Regional Pain Syndrome, Type 1

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).

Interventions

DRUGLenalidamide

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026