Melatonin for Nocturia in patients with Multiple Sclerosis

Phase 1

• Conditions: octuria; Multiple Sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-004183-21-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-14
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 80

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

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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. ;<br> Secondary Objective: 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.<br><br> The aims of the open label, single-arm extension study are to evaluate long-term efficacy and safety.<br> ;Primary end point(s): Reduction in nocturia episodes per night (Frequency Volume Chart/Bladder Diary);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

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Safety of intervention<br> 2. Improvement in the overall quality of life.<br> 3. Improvement in the sleep quality.<br> 4. Change in partner's sleep disturbance is also assessed.<br> ;<br> 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.<br> Secondary endpoint 4 is assessed in a telephone call 2 weeks after the end of the crossover trial.<br>