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

This study has been completed.
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00067743
First received: August 26, 2003
Last updated: December 28, 2007
Last verified: December 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:


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
Other Name: Revlimid

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Donald Manning, MD, PhD, Vice President Clinical Research and Development, Celgene Corportation
ClinicalTrials.gov Identifier: NCT00067743     History of Changes
Other Study ID Numbers: CC-5013-CRPS-001
Study First Received: August 26, 2003
Last Updated: December 28, 2007
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:
Syndrome
Complex Regional Pain Syndromes
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
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014