Botulinum A Toxin in Patients With Parkinson's Disease

NCT00822913 | Unknown Phase 4 DMC

• 1 other identifier: MA-B-PD
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson's Disease; Multiple System Atrophy; Detrusor Overactivity

Keywords

Botulinum A toxin; Parkinson's disease

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Urodynamic assessment, and samples were obtained for urinalysis and culture.

  One, three and five months follow up

Study Arms (1)

Botulinum A toxin

EXPERIMENTAL

Botulinum A toxin intravesical injection

Drug: Intravesical injection of Botulinum A toxin

Interventions

Intravesical injection of Botulinum A toxin DRUG

One treatment, 200 U vials diluted in 20 ml normal saline

Also known as: Allergan

Botulinum A toxin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with overactive bladder symptoms refractory to medical therapy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Of Perugia: lead
• University of Roma La Sapienza: collaborator

MeSH Terms

Conditions

Parkinson Disease; Multiple System Atrophy; Urinary Bladder, Overactive

Interventions

Idoxuridine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Primary Dysautonomias; Autonomic Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Antonella Giannantoni, M.D.

  University Of Perugia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: June 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2009
• Last Updated: January 15, 2009

Record last verified: 2009-01