Back to resultsA Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
Primary Purpose
Complex Regional Pain Syndrome, Type 1
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lenalidamide
Sponsored by
About this trial
This is an interventional treatment trial for Complex Regional Pain Syndrome, Type 1
Eligibility Criteria
Inclusion Criteria: Age > or = to 18 years Signed consent form A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb CRPS pain intensity score at least 4 on an 11-point PI-NRS Measurable sural, median sensory, median motor and peroneal motor nerve conductions 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.
Sites / Locations
- Mayo Clinic
Outcomes
Primary Outcome Measures
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00166452
First Posted
September 12, 2005
Last Updated
March 22, 2011
Sponsor
Mayo Clinic
Collaborators
Elgene Chemical
1. Study Identification
Unique Protocol Identification Number
NCT00166452
Brief Title
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
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 Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
Elgene Chemical
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome, Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lenalidamide
Primary Outcome Measure Information:
Title
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > or = to 18 years
Signed consent form
A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
CRPS pain intensity score at least 4 on an 11-point PI-NRS
Measurable sural, median sensory, median motor and peroneal motor nerve conductions
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith A Bengtson, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
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