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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Roma La Sapienza
Information provided by:
University Of Perugia
ClinicalTrials.gov Identifier:
NCT00822913
First received: January 14, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University Of Perugia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Urodynamic assessment, and samples were obtained for urinalysis and culture. [ Time Frame: One, three and five months follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: June 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00822913

Sponsors and Collaborators
University Of Perugia
University of Roma La Sapienza
Investigators
Principal Investigator: Antonella Giannantoni, M.D. University Of Perugia
  More Information

No publications provided

Responsible Party: Giannantoni Antonella, University of Perugia
ClinicalTrials.gov Identifier: NCT00822913     History of Changes
Other Study ID Numbers: MA-B-PD
Study First Received: January 14, 2009
Last Updated: January 14, 2009
Health Authority: Italy: The Italian Medicines Agency

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

Additional relevant MeSH terms:
Shy-Drager Syndrome
Multiple System Atrophy
Parkinson Disease
Autonomic Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Hypotension
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Primary Dysautonomias
Vascular Diseases
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014