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

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00166452
• Collaborator: Elgene Chemical (Industry)
• Enrollment: 7
• Location: 1
• Duration (Months): 43.1
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Complex Regional Pain Syndrome, Type 1	Drug: Lenalidamide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 7 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
• Study Start Date: Jul 1, 2005
• Actual Primary Completion Date: Apr 1, 2007
• Actual Study Completion Date: Feb 1, 2009

Outcome Measures

Primary Outcome Measures

1. RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Elgene Chemical

Investigators

• Principal Investigator: Keith A Bengtson, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00166452
• Other Study ID Numbers: 422-05
• First Posted: Sep 14, 2005
• Last Update Posted: Mar 23, 2011
• Last Verified: Mar 1, 2011

• Additional relevant MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders

Study Results

No Results Posted as of Mar 23, 2011