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

Primary Purpose

Complex Regional Pain Syndrome (RSD)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide
Sponsored by
Celgene Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Regional Pain Syndrome (RSD) focused on measuring Pain, Pain syndrome, Reflex sympathetic dystrophy, CC-5013, CC5013, Revlimid, Celgene, CRPS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UCSD Center for Pain and Palliative Medicine
  • Johns Hopkins Hospital
  • UNC Hospitals University of North Carolina
  • The Center for Clinical Research
  • Drexel University College of Medicine
  • Swedish Pain Management

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

Open Label trial

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Change in CRPS pain rating in index limb compared to baseline

Full Information

First Posted
August 26, 2003
Last Updated
December 28, 2007
Sponsor
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00067743
Brief Title
A Study of CC-5013 in the Treatment of Complex Regional Pain Syndrome (CRPS)
Acronym
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

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Regional Pain Syndrome (RSD)
Keywords
Pain, Pain syndrome, Reflex sympathetic dystrophy, CC-5013, CC5013, Revlimid, Celgene, CRPS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Open Label trial
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Revlimid
Intervention Description
supplied as 5 mg capsules. Dosing as directed by physician but to start at 10 mg per day
Primary Outcome Measure Information:
Title
Safety
Time Frame
throughout the trial
Secondary Outcome Measure Information:
Title
Change in CRPS pain rating in index limb compared to baseline
Time Frame
throughtout trial compared to baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Manning, MD, PhD
Organizational Affiliation
Celgene Corporation
Official's Role
Study Director
Facility Information:
Facility Name
UCSD Center for Pain and Palliative Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
UNC Hospitals University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7010
Country
United States
Facility Name
The Center for Clinical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Drexel University College of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Swedish Pain Management
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4379
Country
United States

12. IPD Sharing Statement

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

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