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R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00140218
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 8, 2008
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by:
Bennett, James P., Jr., M.D., Ph.D.

Tracking Information
First Submitted Date  ICMJE August 30, 2005
First Posted Date  ICMJE September 1, 2005
Last Update Posted Date January 8, 2008
Study Start Date  ICMJE August 2005
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2008)
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
ALS-FRSr score taken each month for 3 months during lead-in and for 6 months during treatment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2008)
  • FVC taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 months ]
  • hand dynamometry taken each month [ Time Frame: -3 -2 -1 0 1 2 3 4 5 6 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2005)
  • FVC taken each month
  • hand dynamometry taken each month
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Official Title  ICMJE Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis
Brief Summary The hypothesis of this study is that treatment with R(+) pramipexole at 30 mg/day will alter the slope of decline in ALS functional rating scale over the course of 6 months. ALS patients at an early stage of disease will be observed for 3 months after enrollment and then treated with drug for 6 months.
Detailed Description This is a futility design Phase II study using ALS-FRSr as the primary variable to monitor progression of disease in patients with early ALS. The drug to be tested is R(+) pramipexole, an antioxidant that concentrates into brain and mitochondria. R(+)PPX will be administered at 30 mg/day over 6 months, following a 3 month lead-in period without drug therapy. For purposes of this study, futility is defined as failure to decrease the slope of ALS-FRSr decline by less than 40%.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Amyotrophic Lateral Sclerosis
Intervention  ICMJE Drug: R(+) pramipexole dihydrochloride monohydrate
10 mg tid oral
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 5, 2008)
30
Original Enrollment  ICMJE
 (submitted: August 30, 2005)
20
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date January 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • established diagnosis of ALS FVC>60% of predicted not being ventilated no difficulty swallowing ambulatory (can use assistance devices)

Exclusion Criteria:

  • ALS duration >3 years advanced ALS with survival predicted <6 months dementia (MMSE<22) prior exposure to R(+) pramipexole orthostatic hypotension >30 mmHg history of psychosis or hallucinations abnormal baseline safety lab values
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00140218
Other Study ID Numbers  ICMJE 11736
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party James P. Bennett Jr. M.D. Ph.D. Sponsor, University of Virginia
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Bennett, James P., Jr., M.D., Ph.D.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Lawrence H Phillips, M.D. University of Virginia
PRS Account Bennett, James P., Jr., M.D., Ph.D.
Verification Date January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP