Study of Melatonin for treatment of Nocturia in PD
Research type
Research Study
Full title
Single-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease
IRAS ID
147807
Contact name
Jalesh Panicker
Contact email
Eudract number
2014-002697-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
Waking up more than once at night to pass urine, called as nocturia, is one of the commonest problem that an individual with Parkinson's disease (PD) faces. It has a devastating impact on sleep and quality of life, not only in individuals with PD, but also their partners and carers. In fact, there is evidence to suggest that having nocturia puts one at greater risk for sustaining falls, fractures to the hip, and even an increased chance for dying. In spite of the burden that nocturia poses, the treatment options that are currently available for nocturia are few. These include antimuscarinics, percutaneous tibial nerve stimulation (PTNS) and botulinum toxin injections. However it is common for individuals to find these treatments to be either poorly effective or associated with side effects that limit their use.
A different approach would therefore be welcome to address the problem of nocturia. The reasons why nocturia occur is poorly understood but recently there has been some evidence from research studies that suggest that nocturia may be related to changes in the body’s naturally occurring biological clock (otherwise known as the circadian rhythm). Melatonin is a hormone produced by a part of the brain called the pineal gland and plays an important role in controlling the biological clock and has been used to set right the biological clock in individuals with disorders affecting their circadian rhythm. A novel approach to managing nocturia is therefore to try melatonin. There has been a small study in men with prostate troubles that showed that melatonin helped with nocturia, however it has never been studied in PD. Currently, it is available as a drug in the United Kingdom to help with sleeplessness. It has been used in individual with PD before and has been shown to be safe.
This study will explore whether a novel approach of using melatonin will help in managing the troublesome symptom of nocturia in individuals with PD. Twenty individuals with PD reporting significant nocturia will be invited to participate in this study. After providing consent, they will be examined, asked to fill out questionnaires that assess their urinary symptoms, quality of life and sleep. They will fill out a diary (called a frequency-volume chart) recording the amount of fluid they drink, how often they pass urine and the volumes they pass, that will be measured using a measuring jug provided in the study. They will undergo a commonly performed test called urodynamics that will provide information about how their urinary bladder is working. They will be asked to use a special wristwatch (called actigraphy) that will help to monitor their sleep. Participants will be asked to take the drug once a day for six weeks and at the end, the questionnaires and actigraphy will be repeated.
This study will provide some preliminary information about whether melatonin improves nocturia in adults with PD, and will be used to set up a larger study to confirm the findings. This study, therefore potentially opens up a novel treatment using a safe and already available mediation, for the management of a common, yet poorly managed, problem that individuals with PD suffer from.
REC name
London - Hampstead Research Ethics Committee
REC reference
15/LO/0441
Date of REC Opinion
18 Mar 2015
REC opinion
Favourable Opinion