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Botulinum A Toxin in Patients With Parkinson's Disease (Botox-PD)

Primary Purpose

Parkinson's Disease, Multiple System Atrophy, Detrusor Overactivity

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Intravesical injection of Botulinum A toxin
Sponsored by
University Of Perugia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Botulinum A toxin, Parkinson's disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with overactive bladder symptoms refractory to medical therapy.

Exclusion Criteria:

  • Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded.
  • Concomitant anticoagulant therapy or drugs interfering with neuromuscular transmission.
  • Neuromuscular disease like Lambert-Eaton syndrome.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Botulinum A toxin

    Arm Description

    Botulinum A toxin intravesical injection

    Outcomes

    Primary Outcome Measures

    As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).

    Secondary Outcome Measures

    Urodynamic assessment, and samples were obtained for urinalysis and culture.

    Full Information

    First Posted
    January 14, 2009
    Last Updated
    January 14, 2009
    Sponsor
    University Of Perugia
    Collaborators
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00822913
    Brief Title
    Botulinum A Toxin in Patients With Parkinson's Disease
    Acronym
    Botox-PD
    Official Title
    The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    December 2008 (Anticipated)
    Study Completion Date
    December 2009 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Of Perugia
    Collaborators
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The researchers investigated the effectiveness and safety of BoNT/A injected into the detrusor muscle in patients with PD and MSA all of whom had detrusor muscle overactivity unresponsive to conventional medical therapy.
    Detailed Description
    Patients included will have overactive bladder symptoms refractory to medical therapy. Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. None of the patients will be under anticoagulant therapy or drugs interfering with neuromuscular transmission. The study was approved by the local ethical committee and patients gave their informed consent. Patients will be informed about the possible need for intermittent catheterization after BoNT/A treatment. As outcome measures we assessed clinical and urodynamic variables.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease, Multiple System Atrophy, Detrusor Overactivity
    Keywords
    Botulinum A toxin, Parkinson's disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Botulinum A toxin
    Arm Type
    Experimental
    Arm Description
    Botulinum A toxin intravesical injection
    Intervention Type
    Drug
    Intervention Name(s)
    Intravesical injection of Botulinum A toxin
    Other Intervention Name(s)
    Allergan
    Intervention Description
    One treatment, 200 U vials diluted in 20 ml normal saline
    Primary Outcome Measure Information:
    Title
    As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
    Time Frame
    One, three and five months after intravesical treatment
    Secondary Outcome Measure Information:
    Title
    Urodynamic assessment, and samples were obtained for urinalysis and culture.
    Time Frame
    One, three and five months follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients with overactive bladder symptoms refractory to medical therapy. Exclusion Criteria: Other causes of overactive bladder symptoms including urogenital prolapse and recurrent urinary tract infections were excluded. Concomitant anticoagulant therapy or drugs interfering with neuromuscular transmission. Neuromuscular disease like Lambert-Eaton syndrome.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonella Giannantoni, M.D.
    Organizational Affiliation
    University Of Perugia
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Botulinum A Toxin in Patients With Parkinson's Disease

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