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

Sponsor

Celgene Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00067743

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

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 :

Aug 1, 2003

Actual Primary Completion Date :

Oct 1, 2004

Actual Study Completion Date :

Aug 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Revlimid

Arm

Intervention/Treatment

Other: 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 Names:

Revlimid

Outcome Measures

Primary Outcome Measures

Safety [throughout the trial]

Secondary Outcome Measures

Change in CRPS pain rating in index limb compared to baseline [throughtout trial compared to baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	UCSD Center for Pain and Palliative Medicine	La Jolla	California	United States	92093
2	Johns Hopkins Hospital	Baltimore	Maryland	United States	21287
3	UNC Hospitals University of North Carolina	Chapel Hill	North Carolina	United States	27599-7010
4	The Center for Clinical Research	Winston Salem	North Carolina	United States	27103
5	Drexel University College of Medicine	Philadelphia	Pennsylvania	United States	19102
6	Swedish Pain Management	Seattle	Washington	United States	98122-4379