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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00166452
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : March 23, 2011
Elgene Chemical
Information provided by:
Mayo Clinic

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 Type : Interventional  (Clinical Trial)
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 : July 2005
Primary Completion Date : April 2007
Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00166452

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Elgene Chemical
Principal Investigator: Keith A Bengtson, M.D. Mayo Clinic

ClinicalTrials.gov Identifier: NCT00166452     History of Changes
Other Study ID Numbers: 422-05
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: March 23, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Reflex Sympathetic Dystrophy
Pathologic Processes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases