R(+)PPX High Dose Treatment of ALS

Bennett, James P., Jr., M.D., Ph.D.10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Amyotrophic Lateral Sclerosis

Interventions

R(+) pramipexole dihydrochloride monohydrateDRUG

100 mg tid orally daily

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * definite ALS no prior exposure to R(+)PPX Exclusion Criteria: * ALSFRS at baseline \<40 FVC at baseline \<70%

Locations (1)

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

decline in ALSFRS score

Time frame: 6 months

Secondary Outcomes

plasma PPX levels

Time frame: 6 months

CSF PPX levels

Time frame: 6 months

Data from ClinicalTrials.gov

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