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

Arm | Intervention/treatment |
---|---|
Experimental: Botulinum A toxin
Botulinum A toxin intravesical injection
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Drug: Intravesical injection of Botulinum A toxin
One treatment, 200 U vials diluted in 20 ml normal saline
Other Name: Allergan
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- 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 ]
- Urodynamic assessment, and samples were obtained for urinalysis and culture. [ Time Frame: One, three and five months follow up ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
Principal Investigator: | Antonella Giannantoni, M.D. | University Of Perugia |
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 |