A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS) - Full Text View

Sponsor:	Celgene Corporation
Information provided by:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT00067743

Purpose

This is a multicenter, open-label study in adult subjects with Type 1 Complex Regional Pain Syndrome. Subjects diagnosed with unilateral Type 1 CRPS will be enrolled sequentially to receive CC-5013 10 mg/day orally. For each subject the study consists of two phases: Pre-treatment phase(1 wk) and treatment phase (12 wks)

Condition	Intervention	Phase
Complex Regional Pain Syndrome (RSD)	Drug: Lenalidomide	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Multicenter, Open-Label Study to Evaluate the Preliminary Safety and Efficacy of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)

Resource links provided by NLM:

MedlinePlus related topics: Complex Regional Pain Syndrome

Drug Information available for: Lenalidomide CC 5013

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Safety [ Time Frame: throughout the trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in CRPS pain rating in index limb compared to baseline [ Time Frame: throughtout trial compared to baseline ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	August 2003
Study Completion Date:	August 2007
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Open Label trial	Drug: Lenalidomide supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day

Detailed Description:

Once the subject completes the 12 week treatment phase the subject is eligible to continue on the trial. Subjects may continue until no further benefit is obtained.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

A diagnosis of Type 1 CRPS as defined by modified International Association for the Study of Pain criteria (App 1) for at least one year duration
Unilateral involvement of a distal hand or foot with or without proximal speed must be present. The most severely affected limb will be designated the index limb.
CRPS pain severity score in the index limb of 4 or greater on an 11-point (0-10) NRS (Appendix I).
Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants and antidepressant drugs may be continued provided that the subject was on stable doses for at least four weeks prior to the Treatment phase.
Understand and voluntarily sign an informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug.
In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug.
WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
The average CRPS pain severity score in the index limb at the end of the Pre-Treatment Phase I (must be 4 or greater) and 2 each of the daily scores over the week must be within +/- one point of this average.

Exclusion Criteria:

Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
Prior treatment with CC-5013
Prior development of an allergic reaction/hypersensitivity while taking thalidomide.
Prior development of a moderate or sever rash or any desquamation while taking thalidomide.
Pregnant or lactating females.
Active litigation, compensation or disability issues related to CRPS.
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of any other experimental drug or therapy within 28 days of the treatment phase.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00067743

Locations

United States, California
UCSD Center for Pain and Palliative Medicine
La Jolla, California, United States, 92093
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, North Carolina
UNC Hospitals University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7010
The Center for Clinical Research
Winston Salem, North Carolina, United States, 27103
United States, Pennsylvania
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States, 19102
United States, Washington
Swedish Pain Management
Seattle, Washington, United States, 98122-4379

Sponsors and Collaborators

Celgene Corporation

Investigators

Study Director:

Donald Manning, MD, PhD

Celgene Corporation

More Information

No publications provided

Responsible Party:	Celgene Corportation ( Donald Manning, MD, PhD, Vice President Clinical Research and Development )
Study ID Numbers:	CC-5013-CRPS-001
Study First Received:	August 26, 2003
Last Updated:	December 28, 2007
ClinicalTrials.gov Identifier:	NCT00067743 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

Pain
Pain syndrome
Reflex sympathetic dystrophy
CC-5013

CC5013
Revlimid
Celgene
CRPS

Additional relevant MeSH terms:

Disease
Antineoplastic Agents
Nervous System Diseases
Lenalidomide
Pharmacologic Actions
Pathologic Processes
Autonomic Nervous System Diseases

Complex Regional Pain Syndromes
Neuromuscular Diseases
Mental Disorders
Syndrome
Peripheral Nervous System Diseases
Therapeutic Uses
Somatoform Disorders

ClinicalTrials.gov processed this record on November 09, 2009