R(+)PPX High Dose Treatment of ALS

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600873
• Other study ID #: 13023
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 5, 2008
• Last updated: September 10, 2010
• Start date: August 2007
• Est. completion date: January 2009

Study information

• Verified date: September 2010
• 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: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• R(+) pramipexole dihydrochloride monohydrate
100 mg tid orally daily

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Bennett, James P., Jr., M.D., Ph.D.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wang H, Larriviere KS, Keller KE, Ware KA, Burns TM, Conaway MA, Lacomis D, Pattee GL, Phillips LH 2nd, Solenski NJ, Zivkovic SA, Bennett JP Jr. R+ pramipexole as a mitochondrially focused neuroprotectant: initial early phase studies in ALS. Amyotroph Lat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decline in ALSFRS score		6 months	No
Secondary	plasma PPX levels		6 months	No
Secondary	CSF PPX levels		6 months	No