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Sponsored by: |
Celgene Corporation |
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Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00109772 |
The purpose of this multicenter, double-blind, placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.
Condition | Intervention | Phase |
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Complex Regional Pain Syndrome, Type I |
Drug: lenalidomide (CC-5013) Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1 |
Enrollment: | 183 |
Study Start Date: | February 2005 |
Study Completion Date: | April 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo Control Arm
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Drug: Placebo
5mg matching placebo. 2 capsules taken 1 time per day
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Active Arm: Experimental
Active arm
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Drug: lenalidomide (CC-5013)
5 mg capsules, 2 5mg capsules taken one time per day
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This is a multicenter, double-blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1. One hundred eighty (180) subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mg/day of lenalidomide or placebo (90 subjects per treatment arm). For each subject, the study consists of three phases: Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and Extension Phase where subjects have the opportunity to receive lenalidomide treatment as long as a benefit is derived from the drug. Subjects who complete all 12 weeks of the treatment phase may be eligible to receive lenalidomide in the extension phase. Subject may continue in the extension phase as long as a benefit is derived from the drug.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The presence of any of the following will exclude a subject from study enrollment:
Study Director: | Donald C Manning, MD, PhD | Celgene Corporation |
Responsible Party: | Celgene Corporation ( Donald Manning, MD, PhD, Vice President Clinical Research and Development ) |
Study ID Numbers: | CC-5013-CRPS-002 |
Study First Received: | May 3, 2005 |
Last Updated: | October 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00109772 History of Changes |
Health Authority: | United States: Food and Drug Administration |
CRPS RSDS Pain CC-5013 Revlimid Complex Regional Pain Syndrome |
Reflex Sympathy Dystrophy Syndrome Lenalidomide CRPS Type I Celgene Lenalidomide |
Autonomic Nervous System Diseases Reflex Sympathetic Dystrophy Neuromuscular Diseases Complex Regional Pain Syndromes Mental Disorders |
Peripheral Nervous System Diseases Lenalidomide Reflex Sympathetic Dystrophy Syndrome Pain Somatoform Disorders |
Reflex Sympathetic Dystrophy Disease Antineoplastic Agents Nervous System Diseases Lenalidomide Pharmacologic Actions Autonomic Nervous System Diseases Pathologic Processes |
Complex Regional Pain Syndromes Neuromuscular Diseases Mental Disorders Therapeutic Uses Syndrome Peripheral Nervous System Diseases Somatoform Disorders |