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

Primary Purpose

Amyotrophic Lateral Sclerosis

Status
Temporarily not available
Phase
Locations
Study Type
Expanded Access
Intervention
R(+) pramipexole dihydrochloride monohydrate
Sponsored by
Bennett, James P., Jr., M.D., Ph.D.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Amyotrophic Lateral Sclerosis

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • Definite diagnosis of ALS

Exclusion Criteria:

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2008
    Last Updated
    July 24, 2012
    Sponsor
    Bennett, James P., Jr., M.D., Ph.D.
    Collaborators
    University of Pittsburgh, University of Nebraska
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00596115
    Brief Title
    Treating Amyotrophic Lateral Sclerosis (ALS) With R(+) Pramipexole Dihydrochloride Monohydrate at 60 mg/Day
    Official Title
    Open Label Extension for Treating ALS With R(+) Pramipexole at 60 Milligrams Per Day
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    July 2012
    Overall Recruitment Status
    Temporarily not available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bennett, James P., Jr., M.D., Ph.D.
    Collaborators
    University of Pittsburgh, University of Nebraska

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amyotrophic Lateral Sclerosis

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    R(+) pramipexole dihydrochloride monohydrate
    Intervention Description
    20 mg tid per day orally

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    80 Years
    Eligibility Criteria
    Inclusion Criteria: Definite diagnosis of ALS Exclusion Criteria: No prior participation in R(+)PPX clinical studies

    12. IPD Sharing Statement

    Learn more about this trial

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

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