Botulinum A Toxin in Patients With Parkinson's Disease (Botox-PD)
This study is enrolling participants by invitation only.
Sponsor:
University Of Perugia
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
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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:
Drug Information available for:
OnabotulinumtoxinA
Genetic and Rare Diseases Information Center resources:
Multiple System Atrophy
Multiple System Atrophy (MSA) With Orthostatic Hypotension
Proximal Spinal Muscular Atrophy
U.S. FDA Resources
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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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822913
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:
|
Multiple System Atrophy Parkinson Disease Shy-Drager Syndrome 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 February 27, 2015