E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Parkinson's Disease Nocturia |
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E.1.1.1 | Medical condition in easily understood language |
Parkinson's Disease Waking up at night to urinate |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061536 |
E.1.2 | Term | Parkinson's disease |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034007 |
E.1.2 | Term | Parkinson's disease NOS |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | 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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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night 3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of life 5) Sleep disturbance of partners 6)Safety |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria 1. Adults male and female(> 1855 years) with clinically diagnosed PD according to the Brain Bank Criteria 2. Reporting nocturia to NMSQuest item 9 –“Getting up regularly at night to pass urine” and getting up to pass urine two or more times at night. Although the International Continence Society (ICS) defines nocturia as waking up at night one or more times to void, a recent population based study has shown that two voids or more is associated with bother and impaired health related quality of life. 3. Able to provide informed written consent |
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E.4 | Principal exclusion criteria |
Exclusion criteria 1. Montreal Cognitive Assessment (MOCA) score < 26 2. History suggestive of REM sleep behaviour disorder 3. Congestive heart failure, liver failure or kidney failure 4. Uncontrolled diabetes, or significant microalbuminuria in patients with diabetes 5. Using medications such as benzodiazepines and Z-drugs (e.g. Zaleplon, Zolpidem and Zopiclone) 6. Presence of urinary tract infection as determined by the clinician 7. Evidence for incomplete bladder emptying, i.e., post void residual urine of more than 100 mL as determined by ultrasound (bladder scan) 8. Presence of significantly enlarged prostate as determined by the clinician using the European Association of Urology (EAU) guidelines based on urodynamic findings 9. Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation. 10. Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment. 11. Females must not be breastfeeding. 12. Allergies to excipients of IMP and placebo 13. Smokers 14. Patient with autoimmune disease 16. Patients taking carbamazepine, and rifampicin and cimetidine 17. Patients with rare hereditary problems of galactose intolerance, the LAP lactose deficiency or galactose malabsorption 18. excessive Alcohol consumption |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is improvement on bother related to nocturia, as measured by the International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N).
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary outcome will be evaluated at the end of 6 weeks of Melatonin treatment (week 8 of the study). |
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E.5.2 | Secondary end point(s) |
1) Improvement in mean night time urinary frequency assessed from the frequency volume chart and a standardised validated questionnaire, ICIQ-N 2) Improvement in the Nocturnal polyuria index, percentage of volume of urine voided at night, calculated from the frequency volume chart. 3) Improvement in overall lower urinary tract symptoms (LUTS), assessed by standardised validated questionnaires, ie. USP, SF Qualiveen 4) Improvement on sleep disturbances and First uninterrupted sleep period (the time interval between going to bed with the intention of sleeping to waking up for the first void), assessed using a standardised validated questionnaire, Pittsburgh Sleep Quality Index, and Parkinson’s disease sleep scale, sleep diary and Actigraphy 5) Quality of life measured by EQ5D
6) Sleep disturbance in partners/careers assessed by sleep diary and Pittsburgh Sleep Quality Index 7) Adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
2 weeks of the study and again during the 8th week of study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 31 |