R(+)PPX High Dose Treatment of ALS

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00600873

Enrollment

Registered

2008-01-25

Start date

2007-08-31

Completion date

2009-01-31

Last updated

2010-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

neuroprotection, oxidative stress

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.

Interventions

DRUGR(+) pramipexole dihydrochloride monohydrate

100 mg tid orally daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

30 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* ALSFRS at baseline \<40 FVC at baseline \<70%

Design outcomes

Primary

Measure	Time frame
decline in ALSFRS score	6 months

Secondary

Measure	Time frame
plasma PPX levels	6 months
CSF PPX levels	6 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026