R(+)PPX High Dose Treatment of ALS

• ClinicalTrials.gov Identifier: NCT00600873
• Recruitment Status: Completed
• First Posted: January 25, 2008
• Last Update Posted: September 13, 2010
• Sponsor: Bennett, James P., Jr., M.D., Ph.D.
• Information provided by: Bennett, James P., Jr., M.D., Ph.D.

Tracking Information

• First Submitted Date: January 5, 2008
• First Posted Date: January 25, 2008
• Last Update Posted Date: September 13, 2010
• Study Start Date: August 2007
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 15, 2008): decline in ALSFRS score [ Time Frame: 6 months ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 15, 2008)

• plasma PPX levels [ Time Frame: 6 months ]
• CSF PPX levels [ Time Frame: 6 months ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: R(+)PPX High Dose Treatment of ALS
• Official Title: Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months
• 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 Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label)
• Condition: Amyotrophic Lateral Sclerosis

Intervention

Drug: R(+) pramipexole dihydrochloride monohydrate

100 mg tid orally daily

Study Arms

Experimental: 1

patients with early ALS

Intervention: Drug: R(+) pramipexole dihydrochloride monohydrate

• Publications *: 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 Lateral Scler. 2008 Feb;9(1):50-8. doi: 10.1080/17482960701791234.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 15, 2008): 10
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: January 2009
• Actual Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00600873
• Other Study ID Numbers: 13023
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: James P. Bennett Jr. M.D. Ph.D. Sponsor, Virginia Commonwealth University
• Original Responsible Party: James P. Bennett Jr. M.D. Ph.D. Sponsor, University of Virginia
• Current Study Sponsor: Bennett, James P., Jr., M.D., Ph.D.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ted M Burns, MD; University of Virginia

• PRS Account: Bennett, James P., Jr., M.D., Ph.D.
• Verification Date: September 2010