Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day

Clinical Trial Details — Status: Temporarily not available

Administrative data

• NCT number: NCT00596115
• Other study ID #: 12316
• Status: Temporarily not available
• Phase: N/A
• First received: January 5, 2008
• Last updated: July 24, 2012

Study information

• Verified date: July 2012
• Source: Bennett, James P., Jr., M.D., Ph.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Expanded Access

Clinical Trial Summary

R(+) pramipexole dihydrochloride monohydrate [R(+)PPX], an experimental neuroprotective drug, is provided in this open label extension study to ALS patients who have participated in earlier clinical protocols.

Recruitment information / eligibility

• Status: Temporarily not available
• Enrollment: 0
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Definite diagnosis of ALS

Exclusion Criteria:

• No prior participation in R(+)PPX clinical studies

Study Design

N/A

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• R(+) pramipexole dihydrochloride monohydrate
20 mg tid per day orally

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Bennett, James P., Jr., M.D., Ph.D.	University of Nebraska, University of Pittsburgh