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

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

MedlinePlus related topics:

Complex Regional Pain Syndrome

Drug Information available for:

Lenalidomide CC 5013

U.S. FDA Resources

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)

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

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

Study placed in the following topic categories:

Autonomic Nervous System Diseases

Reflex Sympathetic Dystrophy

Neuromuscular Diseases

Complex Regional Pain Syndromes

Mental Disorders

Peripheral Nervous System Diseases

Lenalidomide

Pain

Somatoform Disorders

Reflex sympathetic dystrophy syndrome

Additional relevant MeSH terms:

Pathologic Processes

Disease

Antineoplastic Agents

Therapeutic Uses

Syndrome

Nervous System Diseases

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

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