Clinical Trial Results:
Botulinum neurotoxin type A treatment for sialorrhea in central nervous system diseases
Summary
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EudraCT number |
2015-000682-30 |
Trial protocol |
EE |
Global end of trial date |
12 Nov 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Apr 2022
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First version publication date |
07 Apr 2022
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Other versions |
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Summary report(s) |
Does Botulinum neurotoxin type A treatment for sialorrhea 2017 Saliva changes in Parkinson’s disease patients 2018 Use of botulinum neurotoxin A 2012 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
01-09.02.15.
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Tartu University Hospital
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Sponsor organisation address |
Puusepa 1A, Tartu, Estonia, 50406
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Public contact |
Tartu University Hospital Clinic , Tartu University Hospital Clinic , janne.tiigimae-saar@kliinikum.ee
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Scientific contact |
Tartu University Hospital Clinic , Tartu University Hospital Clinic , janne.tiigimae-saar@kliinikum.ee
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Nov 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
12 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Nov 2018
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
1.Evaluate and compare salivary compositions and microflora change after BNT-A injections describing the status of caries and periodontal health.
2. Evaluate the BNT-A efficiency in treatment of average and hard sialorrhea patients.
3. Evaluate the BNT-A effect on patients life-quality.
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Protection of trial subjects |
Ethics commitee approval obtained. Informed consent obtained.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
30 Mar 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Estonia: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
80
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
12
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
43
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85 years and over |
0
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Recruitment
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Recruitment details |
Totally 67 patients were enrolled to the study group. In the control group there were 13 patients | |||||||||
Pre-assignment
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Screening details |
Informed consent from the patient and/or caregiver was needed. | |||||||||
Period 1
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Period 1 title |
Study group (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Experimental | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Botulinum neurotoxin type A
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intraglandular use
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Dosage and administration details |
250 units
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Arm title
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Control group | |||||||||
Arm description |
- | |||||||||
Arm type |
No intervention | |||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Study group
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | |||||||||||||||||||||||||||||||||
Subject analysis set description |
Subject analysis set is described in the articles
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End points reporting groups
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Reporting group title |
Experimental
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Reporting group description |
- | ||
Reporting group title |
Control group
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Reporting group description |
- | ||
Subject analysis set title |
Per protocol
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Subject analysis set type |
Per protocol | ||
Subject analysis set description |
Subject analysis set is described in the articles
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End point title |
Salivary flow rate | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Resting saliva time, seconds
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Statistical analysis title |
Study result analysis | ||||||||||||
Comparison groups |
Experimental v Control group
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Number of subjects included in analysis |
80
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
t-test, 1-sided | ||||||||||||
Confidence interval |
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Adverse events information
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Timeframe for reporting adverse events |
Starting from study medication injection
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Assessment type |
Systematic | ||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||
Dictionary version |
21
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Reporting groups
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Reporting group title |
All study subjects
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Reporting group description |
All study subjects | ||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |