E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Nocturia; Multiple Sclerosis |
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E.1.1.1 | Medical condition in easily understood language |
Passing urine at night; Multiple Sclerosis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
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 aim is to evaluate whether melatonin medication reduces the number of times a patient with multiple sclerosis has to get out of bed at night to pass urine. |
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E.2.2 | Secondary objectives of the trial |
Secondary aims are to evaluate; 1) Improvement in quality of life, 2) safety, 3) lower urinary tract symptoms (LUTS), 4) total voided (urinated) volume and mean volume per void, 5) sleep quality and 6) sleep disturbance of partners.
The aims of the open label, single-arm extension study are to evaluate long-term efficacy and safety.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Over 18 years old - Confirmed neurological diagnosis of multiple sclerosis - At least 1 episode of nocturia (as defined by International Continence Society criteria [6]) every night - Female subjects of child-bearing potential; willing to use an effective method of contraception throughout the study
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E.4 | Principal exclusion criteria |
- Under 18 years old - Pregnant patients - Symptomatic urinary infection - Indwelling urinary catheter - Use of desmopressin or investigational medical compounds in the month preceding randomization - Antimuscarinic or diuretic medication, unless used long-term prior to study (at least 3 months) and continued at same dosing regime throughout the study - Use of melatonin on prescription, or purchased over-the-counter/ online - Use of “sleeping tablets” on prescription, or purchased over-the-counter/ online - Diabetes mellitus - Diabetes insipidus - Unwilling to give informed consent - Female subjects of child-bearing potential; unwilling to use an effective method of contraception throughout the study
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction in nocturia episodes per night (Frequency Volume Chart/Bladder Diary) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The primary endpoint is evaluated at the end of the active treatment phase, and is compared with the same endpoint at the end of the placebo phase for this crossover study |
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E.5.2 | Secondary end point(s) |
1. Safety of intervention 2. Improvement in the overall quality of life. 3. Improvement in the sleep quality. 4. Change in partner's sleep disturbance is also assessed.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary endpoints 1-3 are evaluated at the end of the active treatment phase, and compared with the same endpoint at the end of the placebo phase for this crossover study. Secondary endpoint 4 is assessed in a telephone call 2 weeks after the end of the crossover trial. |
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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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |