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

This study has been completed.
Sponsor:
Collaborator:
Elgene Chemical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00166452
First received: September 12, 2005
Last updated: March 22, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Complex Regional Pain Syndrome, Type 1
Drug: Lenalidamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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

Enrollment: 7
Study Start Date: July 2005
Study Completion Date: February 2009
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166452

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

No publications provided

ClinicalTrials.gov Identifier: NCT00166452     History of Changes
Other Study ID Numbers: 422-05
Study First Received: September 12, 2005
Last Updated: March 22, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Somatoform Disorders
Complex Regional Pain Syndromes
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on April 16, 2014