Melatonin for Nocturia in patients with Multiple Sclerosis

A randomized, double blind, placebo controlled, cross over trial of Melatonin for the treatment of nocturia in adults with progressive multiple sclerosis, with an open label, single-arm extension study - Melatonin for Nocturia in MS

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004183-21-GB

Enrollment

Registered

2012-12-14

Start date

2013-01-25

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia

Interventions

Trade Name: Circadin Product Name: Circadin Product Code: N/A Pharmaceutical Form: Modified-release tablet INN or Proposed INN: Circadin

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. ; 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. The aims of the open label, single-arm extension study are to evaluate long-term efficacy and safety. ;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	—

Measure

Time frame

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. ; 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. The aims of the open label, single-arm extension study are to evaluate long-term efficacy and safety. ;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

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Secondary

Measure	Time frame
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. ; 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.	—

Measure

Time frame

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. ; 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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Countries

United Kingdom

Contacts

Public ContactProfessor Marcus Drake

North Bristol NHS Trust

marcus.drake@bui.ac.uk01173235690

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026