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R(+)PPX High Dose Treatment of ALS

NCT ID: NCT00600873

Last Updated: 2010-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-01-31

Brief Summary

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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

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Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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1

patients with early ALS

Group Type EXPERIMENTAL

R(+) pramipexole dihydrochloride monohydrate

Intervention Type DRUG

100 mg tid orally daily

Interventions

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R(+) pramipexole dihydrochloride monohydrate

100 mg tid orally daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* definite ALS no prior exposure to R(+)PPX

Exclusion Criteria

* ALSFRS at baseline \<40 FVC at baseline \<70%
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDIV

Sponsor Role lead

Responsible Party

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Virginia Commonwealth University

Principal Investigators

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Ted M Burns, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 18270879 (View on PubMed)

Other Identifiers

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13023

Identifier Type: -

Identifier Source: org_study_id