R(+)PPX High Dose Treatment of ALS

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

Status and phase: Completed; Phase 2; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: R(+) pramipexole dihydrochloride monohydrate

Study type: Interventional

Identifiers

NCT00600873

13023

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• ALSFRS at baseline <40 FVC at baseline <70%

Trial design

10 participants in 1 patient group

1

Experimental group

Description:

patients with early ALS

Treatment:

Drug: R(+) pramipexole dihydrochloride monohydrate