R(+)PPX High Dose Treatment of ALS

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis
• Interventions: Drug: R(+) pramipexole dihydrochloride monohydrate

• Registration Number: NCT00600873
• Lead Sponsor: Bennett, James P., Jr., M.D., Ph.D.

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 available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2008-01-05
• Study First Submitted QC: 2008-01-15
• Study First Posted: 2008-01-25
• Primary Completion: 2008-09
• Study Completion: 2009-01
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-10
• Last Update Posted: 2010-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	R(+) pramipexole dihydrochloride monohydrate	patients with early ALS

Primary Outcome Measures

Name	Time	Method
decline in ALSFRS score	6 months

Secondary Outcome Measures

Name	Time	Method
plasma PPX levels	6 months
CSF PPX levels	6 months

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States