A Study of the Effect of Lenalidamide on Complex Regional... | NCT00166452

Studies
A Study of the Effect of Lenalidamide on Complex Regional Pain Syndrome Type 1

NCT00166452

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Mar 23, 2011Estimated

Enrollment

7Actual

Phase

Phase 3

Conditions

Complex Regional Pain Syndrome, Type 1

Interventions

Lenalidamide

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2005

Primary Completion Date

Apr 2007Actual

Completion Date

Feb 2009Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 14, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2011

Last Update Posted Date

Mar 23, 2011Estimated

Name	Class
Elgene Chemical	INDUSTRY

Description Module

Brief Summary

The purpose of this study is to determine if lenalidomide is a safe and effective treatment for complex regional pain syndrome type 1 (CRPS).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Name	Type	Description	Arm Group Labels	Other Names
Lenalidamide	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
RPS Pain Intensity Numeric Rating Scale (PI-NRS): At least 30% reduction from baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > or = to 18 years
Signed consent form
A diagnosis of CRPS type I for at least one-year duration with unilateral involvement of a distal limb
CRPS pain intensity score at least 4 on an 11-point PI-NRS
Measurable sural, median sensory, median motor and peroneal motor nerve conductions
Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting the study drug. They must agree to use adequate contraceptive methods not including steroid-based contraceptives. They must also agree to have pregnancy tests every 4 weeks while on the study drug.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Keith A Bengtson, M.D.	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Rochester	Minnesota	55905	United States

Condition Browse Module

MeSH Terms

ID	Term
D020918	Complex Regional Pain Syndromes

Ancestor Terms

ID	Term
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided