Clinical Trial Results:
Can local intramuscular botulinum toxin improve dysphagia in patients with myopathic dysphagia and constriction of the cricoid muscle?
Summary
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EudraCT number |
2014-002210-23 |
Trial protocol |
DK |
Global end of trial date |
28 Nov 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
08 Jan 2021
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First version publication date |
08 Jan 2021
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Other versions |
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 |
1.4botox
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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 |
Rigshospitalet
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Sponsor organisation address |
BLEGDAMSVEJ 9, Københaven Ø, Denmark,
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Public contact |
Neurology 2081, Rigshospitalet, 45 35459674, nanna.witting@regionh.dk
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Scientific contact |
Neurology 2081, Rigshospitalet, 45 35459674, nanna.witting@regionh.dk
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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 |
19 Nov 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Nov 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
28 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 |
To investigate if local intramuscular botulinum toxin can alleviate myopahtic dysphagia
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Protection of trial subjects |
None
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Background therapy |
One had prednisolone | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jul 2014
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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 |
Denmark: 13
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Worldwide total number of subjects |
13
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EEA total number of subjects |
13
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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) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
13
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85 years and over |
0
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Recruitment
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Recruitment details |
From own clinic and collaborators. | ||||||||
Pre-assignment
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Screening details |
Dysphagia score | ||||||||
Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||
Arms
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Arm title
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Dysphagiascore | ||||||||
Arm description |
Three ascending doses og drug. | ||||||||
Arm type |
Active comparator | ||||||||
Investigational medicinal product name |
botulinum toxin A
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
5-25 units in the cricopharyngeal muscle bilaterally
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Baseline characteristics reporting groups
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Reporting group title |
Treatment period
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Best 12W dyspahgia score or latest measurement
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Subject analysis set type |
Intention-to-treat | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
Best 12W dyspahgia score or latest measurement compared to baseline
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End points reporting groups
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Reporting group title |
Dysphagiascore
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Reporting group description |
Three ascending doses og drug. | ||
Subject analysis set title |
Best 12W dyspahgia score or latest measurement
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
Best 12W dyspahgia score or latest measurement compared to baseline
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End point title |
Best 12w dysphagia score or latest measurement compared to baseline [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Best 12w dysphagia score or latest measurement
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: An Attachment with raw data and statistical analysis is provided. |
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Attachments |
Botox results |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
12 weeks after last injection.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
none | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 0% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No non-serious adverse events were reported. One person had a rash after injection. |
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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 |