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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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15 July 2013 |
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Main ID: |
EUCTR2009-017412-32-IT |
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Date of registration:
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27/04/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND
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Scientific title:
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RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND |
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Date of first enrolment:
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13/12/2011 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017412-32 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
Parkinson disease patients (>18 yrs) Drooling >2 (UPDRS-II) Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
previous or contraindications to botulinum toxin injections presence of comorbilities (alcool addiction, HIV, psychiatric or endocrine disease), pregnancy
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Parkinson disease
MedDRA version: 9.1
Level: LLT
Classification code 10013363
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Intervention(s)
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Trade Name: BOTOX
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Botulinum toxin
Concentration unit: U unit(s)
Concentration type: equal
Concentration number: 100-
Trade Name: NEUROBLOC
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Botulinum toxin
Concentration unit: IU/ml international unit(s)/millilitre
Concentration type: equal
Concentration number: 5000-
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Primary Outcome(s)
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Primary end point(s): Drooling reduction 1 month after botulinum toxin injections evautated according to UPDRS-II
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Main Objective: To evaluate botulinum toxin type A and B in the treatment of drooling in parkinson disease
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Secondary Objective: To evaluate the safety of the treatament
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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