Clinical trial NCT00067743: A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complex Regional Pain Syndrome (RSD)
Keywords: Pain
Pain syndrome
Reflex sympathetic dystrophy
CC-5013
CC5013
Revlimid
Celgene
CRPS
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2003-08-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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 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.

Primary outcomes:
measure: Safety
timeFrame: throughout the trial
Secondary outcomes:
measure: Change in CRPS pain rating in index limb compared to baseline
timeFrame: throughtout trial compared to baseline
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UCSD Center for Pain and Palliative Medicine
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Chapel Hill
country: United States
facility: UNC Hospitals University of North Carolina
state: North Carolina
city: Winston Salem
country: United States
facility: The Center for Clinical Research
state: North Carolina
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Pain Management
state: Washington
Study officials:
affiliation: Celgene Corporation
name: Donald Manning, MD, PhD
role: STUDY_DIRECTOR
References: