Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109772
Status:
TERMINATED
Last Update Posted:
2013-08-28
First Post:
2005-05-03
Brief Title:
Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
Sponsor:
Celgene Corporation
Organization:
Celgene
Study Overview
Official Title:
A Multicenter Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1
Status:
TERMINATED
Status Verified Date:
2013-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Interim analysis showed the primary outcome was not reached
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRPS-002
Brief Summary:
The purpose of this multicenter double-blind placebo-controlled study is to evaluate the efficacy and safety of Lenalidomide in adult subjects with Complex Regional Pain Syndrome CRPS Type 1
Detailed Description:
This is a multicenter double-blind placebo-controlled study in adult subjects with Complex Regional Pain Syndrome CRPS Type 1
One hundred eighty 180 subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mgday of lenalidomide or placebo 90 subjects per treatment arm For each subject the study consists of three phases Pre-randomization Phase 2 weeks Treatment Phase 12 weeks and Extension Phase where subjects have the opportunity to receive lenalidomide treatment as long as a benefit is derived from the drug Subjects who complete all 12 weeks of the treatment phase may be eligible to receive lenalidomide in the extension phase Subject may continue in the extension phase as long as a benefit is derived from the drug
One hundred eighty 180 subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mgday of lenalidomide or placebo 90 subjects per treatment arm For each subject the study consists of three phases Pre-randomization Phase 2 weeks Treatment Phase 12 weeks and Extension Phase where subjects have the opportunity to receive lenalidomide treatment as long as a benefit is derived from the drug Subjects who complete all 12 weeks of the treatment phase may be eligible to receive lenalidomide in the extension phase Subject may continue in the extension phase as long as a benefit is derived from the drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None