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

NCT00067743 | Completed Phase 2 DMC

• 1 other identifier: CC-5013-CRPS-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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)

Conditions

Complex Regional Pain Syndrome (RSD)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety

  throughout the trial

Secondary Outcomes (1)

• Change in CRPS pain rating in index limb compared to baseline

  throughtout trial compared to baseline

Study Arms (1)

1

OTHER

Open Label trial

Drug: Lenalidomide

Interventions

Lenalidomide DRUG

supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day

Also known as: Revlimid

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (6)

UCSD Center for Pain and Palliative Medicine

La Jolla, California, 92093, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

UNC Hospitals University of North Carolina

Chapel Hill, North Carolina, 27599-7010, United States

Location

The Center for Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

Drexel University College of Medicine

Philadelphia, Pennsylvania, 19102, United States

Location

Swedish Pain Management

Seattle, Washington, 98122-4379, United States

Location

MeSH Terms

Conditions

Complex Regional Pain Syndromes; Pain; Somatoform Disorders; Reflex Sympathetic Dystrophy

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Donald Manning, MD, PhD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 26, 2003
• First Posted: August 27, 2003
• Study Start: August 1, 2003
• Primary Completion: October 1, 2004
• Study Completion: August 1, 2007
• Last Updated: January 3, 2008

Record last verified: 2006-12

Locations

US (6)