Condition category
Urological and Genital Diseases
Date applied
04/04/2013
Date assigned
04/04/2013
Last edited
04/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Julie Ellis-Jones

ORCID ID

Contact details

Bristol Urological Institute
Southmead Hospital
Southmead Road Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
julie.ellis-jones@nbt.nhs.uk

Additional identifiers

EudraCT number

2012-004183-21

ClinicalTrials.gov number

Protocol/serial number

13586

Study information

Scientific title

A randomised, double blind, placebo controlled, crossover trial of melatonin for treatment of nocturia in adults with multiple sclerosis

Acronym

Study hypothesis

This study is to assess the effect of melatonin in patients with Multiple Sclerosis (MS). Melatonin is a natural hormone regulating circadian cycles, it is released by the brain's pineal gland at night-time, and varying with sleep state. It also reduces smooth muscle activity in the bladder. MS is a neurological disease affecting the myelin coat on nerve fibres.

In primary and secondary progressive MS urinary symptoms are common, including nocturia, along with sleep disturbance from other causes (e.g. restless legs syndrome, anxiety, etc.). Quality of life impact is substantial; fatigue leads to reduced capacity to carry out daily activities, which is a particular problem in a disabled patient group.

Melatonin has been used for nocturia in two small studies, in men with benign prostate enlargements, and also in a group of elderly patients; both groups showed a beneficial symptom response in addition to improving their quality of life. This trial is a double-blind randomised placebo controlled crossover clinical trial to compare sustained-release melatonin against placebo in patients with Multiple Sclerosis. A run-in phase will be followed by two treatment phases (active drug or placebo) of 6 weeks each separated by a washout interval of 1 month. After the second treatment phase, patients will be entitled to participate in an open label, single-arm extension study of duration one year. Qualitative interviews will be undertaken with participants to assess the impact of nocturia on their quality of life.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=13586

Ethics approval

Not provided at time of registration

Study design

Double-blind randomised placebo controlled crossover clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Topic: Renal and Urogenital, Nocturia in adults with multiple sclerosis

Intervention

Sustained-release melatonin versus placebo in patients with Multiple Sclerosis.

A run-in phase will be followed by two treatment phases (active drug or placebo) of 6 weeks each separated by a washout interval of 1 month. After the second treatment phase, patients will be entitled to participate in an open label, single-arm extension study of duration one year. Qualitative interviews will be undertaken with participants to assess the impact of nocturia on their quality of life.

Intervention type

Drug

Phase

Not Applicable

Drug names

Melatonin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/03/2013

Overall trial end date

25/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female over 18 years old, upper age limit 80 years
2. Confirmed neurological diagnosis of multiple sclerosis.
3. At least 1 episode of nocturia (as defined by International Continence Society criteria [6]) every night.
4. Female subjects of childbearing potential; willing to use an effective method of contraception throughout the study.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 50

Participant exclusion criteria

1. Under 18 years old
2. Pregnant patients
3. Symptomatic urinary infection
4. Indwelling urinary catheter
5. Use of desmopressin or investigational medical compounds in the month preceding randomisation
6. Antimuscarinic or diuretic medication, unless used longterm prior to study (at least 3 months) and continued at same dosing regime throughout the study
7. Use of melatonin on prescription, or purchased over the counter/online
8. Use of “sleeping tablets” on prescription, or purchased overt he counter/ online
9. Diabetes mellitus
10. Diabetes insipidus
11. Unwilling to give informed consent
12. Female subjects of childbearing potential; unwilling to use an effective method of contraception throughout the study

Recruitment start date

25/03/2013

Recruitment end date

25/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bristol Urological Institute
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust (UK)

Sponsor details

Trust Headquarters
Beckspool Road
Frenchay
Bristol
B16 1JE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.nbt.nhs.uk/

Funders

Funder type

Charity

Funder name

Multiple Sclerosis Society (of Great Britain & Northern Ireland) (UK) Grant Codes: 959/11

Alternative name(s)

MS Society

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes