R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

January 5, 2008 updated by: Bennett, James P., Jr., M.D., Ph.D.

Futility Study of R(+) Pramipexole in Early Amyotrophic Lateral Sclerosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • David Lacomis MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
-3 -2 -1 0 1 2 3 4 5 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
FVC taken each month
Time Frame: -3 -2 -1 0 1 2 3 4 5 6 months
-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
-3 -2 -1 0 1 2 3 4 5 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bennett, James P., Jr., M.D., Ph.D.

Collaborators

University of Pittsburgh

Investigators

  • Principal Investigator: Lawrence H Phillips, M.D., University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

January 1, 2007

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

August 30, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (ESTIMATE)

September 1, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 8, 2008

Last Update Submitted That Met QC Criteria

January 5, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11736 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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