R(+)PPX High Dose Treatment of ALS | NCT00600873

Studies
R(+)PPX High Dose Treatment of ALS

NCT00600873

Sponsor

Bennett, James P., Jr., M.D., Ph.D.

Status

Completed

Last Update Posted

Sep 13, 2010Estimated

Enrollment

10Actual

Phase

Phase 1Phase 2

Conditions

Amyotrophic Lateral Sclerosis

Interventions

R(+) pramipexole dihydrochloride monohydrate

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Yes

Start Date

Aug 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Jan 5, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 25, 2008Estimated

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

Sep 10, 2010

Last Update Posted Date

Sep 13, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	patients with early ALS	Drug: R(+) pramipexole dihydrochloride monohydrate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
R(+) pramipexole dihydrochloride monohydrate	Drug	100 mg tid orally daily	1

Measure	Description	Time Frame
decline in ALSFRS score		6 months

Measure	Description	Time Frame
plasma PPX levels		6 months
CSF PPX levels		6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

definite ALS no prior exposure to R(+)PPX

Exclusion Criteria:

ALSFRS at baseline <40 FVC at baseline <70%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ted M Burns, MD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18270879	Result	Wang H, Larriviere KS, Keller KE, Ware KA, Burns TM, Conaway MA, Lacomis D, Pattee GL, Phillips LH 2nd, Solenski NJ, Zivkovic SA, Bennett JP Jr. R+ pramipexole as a mitochondrially focused neuroprotectant: initial early phase studies in ALS. Amyotroph Lateral Scler. 2008 Feb;9(1):50-8. doi: 10.1080/17482960701791234.

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D016472	Motor Neuron Disease