Clinical Trial Results:
Single-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease
Summary
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EudraCT number |
2014-002697-37 |
Trial protocol |
GB |
Global end of trial date |
07 Dec 2018
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Nov 2020
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First version publication date |
14 Nov 2020
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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 |
14/0382
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02359448 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
University College London
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Sponsor organisation address |
Gower Steet, London, United Kingdom,
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Public contact |
Joint Research Office, UCL, CTIMPS@ucl.ac.uk
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Scientific contact |
Joint Research Office, UCL, CTIMPS@ucl.ac.uk
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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 |
07 Dec 2018
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
07 Dec 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
07 Dec 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 |
The primary objective of this study is to evaluate the effects of melatonin on bother related to nocturia.
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Protection of trial subjects |
Patients were closely monitored throughout the length of the clinical trial by members of the study team
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 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 |
United Kingdom: 28
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Worldwide total number of subjects |
28
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EEA total number of subjects |
28
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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) |
13
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From 65 to 84 years |
15
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
Pre-assignment
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Screening details |
We included over 18 year old patients reporting nocturia based on to NMSQuest item 9 –“Getting up regularly at night to pass urine” two or more times at night. | ||||||
Period 1
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Period 1 title |
Main study 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 | ||||||
Blinding implementation details |
Open label
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Arms
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Arm title
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Melatonin | ||||||
Arm description |
Melatonin treatment arm | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
Melatonin
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Prolonged-release tablet
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Routes of administration |
Oral use
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Dosage and administration details |
2mg
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End points reporting groups
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Reporting group title |
Melatonin
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Reporting group description |
Melatonin treatment arm |
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End point title |
Improvement on bother related to nocturia, as measured by the International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N). [1] | ||||||||
End point description |
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End point type |
Primary
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End point timeframe |
The primary outcome will be evaluated at the end of 6 weeks of Melatonin treatment (week 8 of the study).
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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: statistical analysis for ICIQ-N was non-parametric Wilcoxon signed–ranked test |
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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 |
during the course of the study
No serious adverse events reported
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
CTCAE | ||
Dictionary version |
4
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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 adverse events were recorded during the trial due to the safety profile of the drug. The drug is a marketed product with low risk associated with it, therefore no SAE's were reported |
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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 |