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

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ClinicalTrials.gov Identifier: NCT00822913
Recruitment Status : Unknown
Verified January 2009 by University Of Perugia.
Recruitment status was:  Enrolling by invitation
First Posted : January 15, 2009
Last Update Posted : January 15, 2009
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by:
University Of Perugia

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Multiple System Atrophy Detrusor Overactivity Drug: Intravesical injection of Botulinum A toxin Phase 4

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Estimated Primary Completion Date : December 2008
Estimated Study Completion Date : December 2009

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botulinum A toxin
Botulinum A toxin intravesical injection
 Drug: Intravesical injection of Botulinum A toxin
One treatment, 200 U vials diluted in 20 ml normal saline
Other Name: Allergan


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Urodynamic assessment, and samples were obtained for urinalysis and culture. [ Time Frame: One, three and five months follow up ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822913


Sponsors and Collaborators
University Of Perugia
University of Roma La Sapienza
Investigators
Principal Investigator: Antonella Giannantoni, M.D. University Of Perugia
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Giannantoni Antonella, University of Perugia
ClinicalTrials.gov Identifier: NCT00822913     History of Changes
Other Study ID Numbers: MA-B-PD
First Posted: January 15, 2009    Key Record Dates
Last Update Posted: January 15, 2009
Last Verified: January 2009

Keywords provided by University Of Perugia:
Botulinum A toxin
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
 Hypotension
Vascular Diseases
Cardiovascular Diseases
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents