Parkinson's DiseasePhase 4Botox-PDNCT00822913
Botulinum A Toxin in Patients With Parkinson's Disease
A Phase 4 study testing Intravesical injection of Botulinum A toxin in people with Parkinson's Disease and Multiple System Atrophy, run by University Of Perugia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Multiple System Atrophy, Detrusor Overactivity
- What is being tested?
- Intravesical injection of Botulinum A toxin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with overactive bladder symptoms refractory to medical therapy.
Who cannot join
- 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.
About this study
Official title: The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.
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.
Read the 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.
- Being tested
- Intravesical injection of Botulinum A toxin
- Keywords
- Botulinum A toxin, Parkinson's disease
- Medical subject headings
- Parkinson Disease, Multiple System Atrophy, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical injection of Botulinum A toxinDrug
Also called Allergan
One treatment, 200 U vials diluted in 20 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| Botulinum A toxin | Experimental | Botulinum A toxin intravesical injection Receives: Drug: Intravesical injection of Botulinum A toxin |
What is being measured
The primary outcome is the main question the study is designed to answer.
As primary outcome measures, patients attended for clinical evaluation (daily voiding diary an QoL questionnaire).
Measured: One, three and five months after intravesical treatment
Secondary outcomes (1)
Urodynamic assessment, and samples were obtained for urinalysis and culture.
Measured: One, three and five months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2009 (estimated)
- Study startJun 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Of Perugia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Roma La Sapienza
- Investigators
- Antonella Giannantoni, M.D., Principal investigator, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822913
- Sponsor's protocol ID
- MA-B-PD
- Acronym
- Botox-PD
- Status last verified
- Jan 2009
- First submitted
- 14 Jan 2009
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.
- ClinicalTrials.gov ID
- NCT00822913
- Acronym / sponsor ID
- Botox-PD / MA-B-PD
- Keywords
- Botulinum A toxin, Parkinson's disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Of PerugiaUniversity, hospital or other
- Collaborators
- University of Roma La Sapienza
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 15 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Botulinum A toxin | Experimental | Drug: Intravesical injection of Botulinum A toxinBotulinum A toxin intravesical injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with overactive bladder symptoms refractory to medical therapy.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical injection of Botulinum A toxinAlso: AllerganOne treatment, 200 U vials diluted in 20 ml normal saline | Drug | Botulinum A toxin |
Primary outcome
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
1 secondary outcome
Urodynamic assessment, and samples were obtained for urinalysis and culture.
Time frame: One, three and five months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Giannantoni, M.D. principal investigator
University Of Perugia
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravesical injection of Botulinum A toxin in people with Parkinson's Disease and Multiple System Atrophy, run by University Of Perugia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2009.