- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00166452
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1
March 22, 2011 updated by: Mayo Clinic
Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidamide in the Treatment of Complex Regional Pain Syndrome Type1
The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Keith A Bengtson, M.D., Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
April 1, 2007
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
March 23, 2011
Last Update Submitted That Met QC Criteria
March 22, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 422-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complex Regional Pain Syndrome, Type 1
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Hospices Civils de LyonRecruitingNeuropathic Pain | Complex Regional Pain Syndrome Type 1France
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University of GiessenWithdrawnComplex Regional Pain Syndrome Type 1Germany
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Ruhr University of BochumUnknownComplex Regional Pain Syndrome Type I of the Upper LimbGermany
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Hospital for Special Surgery, New YorkNot yet recruitingChronic Pain | Complex Regional Pain Syndrome | Causalgia | Complex Regional Pain Syndrome Type I | Complex Regional Pain Syndrome Type IIUnited States
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University of GroningenWithdrawnComplex Regional Pain Syndrome Type I of the Upper LimbNetherlands
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University of ZurichBalgrist University HospitalRecruitingComplex Regional Pain Syndrome I (CRPS I) | Complex Regional Pain Syndromes | Osteoarthritis Hand | Complex Regional Pain Syndrome Type II | Complex Regional Pain Syndrome Type I of the Upper Limb | Complex Regional Pain Syndrome I of Upper Limb | Complex Regional Pain Syndrome II of Upper Limb | Peripheral Nerve Injury Upper Limb and other conditionsSwitzerland
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National Institute of Nursing Research (NINR)National Institutes of Health Clinical Center (CC); Eunice Kennedy Shriver... and other collaboratorsTerminatedComplex Regional Pain Syndrome Type I | Complex Regional Pain Syndrome Type IIUnited States
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Medical University of ViennaUnknown
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Grünenthal GmbHCompletedComplex Regional Pain Syndrome, Type IUnited States, Germany, United Kingdom
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State University of New York - Upstate Medical...Reflex Sympathetic Dystrophy Syndrome Association (RSDSA)RecruitingComplex Regional Pain Syndrome Type IUnited States