Botulinum A Toxin in Patients With Parkinson's Disease | NCT00822913

Studies
Botulinum A Toxin in Patients With Parkinson's Disease

NCT00822913

Sponsor

University Of Perugia

Status

Unknown status

Last Update Posted

Jan 15, 2009Estimated

Enrollment

20Estimated

Phase

Phase 4

Conditions

Parkinson's Disease
Multiple System Atrophy
Detrusor Overactivity

Interventions

Intravesical injection of Botulinum A toxin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Jan 14, 2009

First Submission Date that Met QC Criteria

Jan 14, 2009

First Posted Date

Jan 15, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2009

Last Update Posted Date

Jan 15, 2009Estimated

Name	Class
University of Roma La Sapienza	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Botulinum A toxin	Experimental	Botulinum A toxin intravesical injection	Drug: Intravesical injection of Botulinum A toxin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravesical injection of Botulinum A toxin	Drug	One treatment, 200 U vials diluted in 20 ml normal saline	Botulinum A toxin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).		One, three and five months after intravesical treatment

Secondary Outcomes

Measure	Description	Time Frame
Urodynamic assessment, and samples were obtained for urinalysis and culture.		One, three and five months follow up

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Antonella Giannantoni, M.D.	University Of Perugia	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease
D019578	Multiple System Atrophy
D053201	Urinary Bladder, Overactive

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007065	Idoxuridine

Ancestor Terms

ID	Term
D003857	Deoxyuridine
D014529	Uridine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided