R(+)PPX High Dose Treatment of ALS

This study has been completed.

Sponsor:

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00600873

First received: January 5, 2008

Last updated: September 10, 2010

Last verified: September 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

January 5, 2008

Last Updated Date

September 10, 2010

Start Date ^ICMJE

August 2007

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

decline in ALSFRS score [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00600873 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

plasma PPX levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]
CSF PPX levels [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

R(+)PPX High Dose Treatment of ALS

Official Title ^ICMJE

Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months

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

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Amyotrophic Lateral Sclerosis

Intervention ^ICMJE

Drug: R(+) pramipexole dihydrochloride monohydrate

100 mg tid orally daily

Study Arm (s)

Experimental: 1

patients with early ALS

Intervention: Drug: R(+) pramipexole dihydrochloride monohydrate

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

definite ALS no prior exposure to R(+)PPX

Exclusion Criteria:

ALSFRS at baseline <40 FVC at baseline <70%

Gender

Both

Ages

30 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00600873

Other Study ID Numbers ^ICMJE

13023

Has Data Monitoring Committee

Yes

Responsible Party

James P. Bennett Jr. M.D. Ph.D. Sponsor, Virginia Commonwealth University

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ted M Burns, MD

University of Virginia

Information Provided By

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

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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