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

• ClinicalTrials.gov Identifier: NCT00067743
• Recruitment Status: Completed
• First Posted: August 27, 2003
• Last Update Posted: January 3, 2008
• Sponsor: Celgene Corporation
• Information provided by: Celgene

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Complex Regional Pain Syndrome (RSD)	Drug: Lenalidomide	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Study Start Date: August 2003
• Actual Primary Completion Date: October 2004
• Actual Study Completion Date: August 2007

Arms and Interventions

Arm	Intervention/treatment
1; Open Label trial	Drug: Lenalidomide; supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day; Other Name: Revlimid

Outcome Measures

Primary Outcome Measures :

1. Safety [ Time Frame: throughout the trial ]

Secondary Outcome Measures :

1. Change in CRPS pain rating in index limb compared to baseline [ Time Frame: throughtout trial compared to baseline ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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: Donald Manning, MD, PhD, Vice President Clinical Research and Development, Celgene Corportation
• ClinicalTrials.gov Identifier: NCT00067743
• Other Study ID Numbers: CC-5013-CRPS-001
• First Posted: August 27, 2003
• Last Update Posted: January 3, 2008
• Last Verified: December 2006

Keywords provided by Celgene:

Pain; Pain syndrome; Reflex sympathetic dystrophy; CC-5013; CC5013; Revlimid; Celgene; CRPS

Additional relevant MeSH terms:

Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Somatoform Disorders; Disease; Pathologic Processes; Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Lenalidomide; Immunologic Factors; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Antineoplastic Agents