NCT02359448

Melatonin for Nocturia in Parkinson's Disease

Single-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's Disease

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an an open label clinical trial of sustained-release Melatonin 2mg once daily for 12 weeks in patients with Parkinsons's Disease reporting nocturia, defined as getting up regularly at night \> twice to pass urine. The primary objective of this study is to evaluate the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are to evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night 3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of life 5) Sleep disturbance of partners 6)Safety

Detailed description

This is a Phase IIb, open label single-site trial of sustained-release Melatonin 2mg in patients with PD, reporting nocturia, defined as getting up regularly at night \> twice to pass urine. The primary objective of this study is to evaluate the effects of exogenous melatonin on bother related to nocturia. Secondary objectives are to evaluate: 1) Mean night time urinary frequency 2)Volume of urine voided at night 3)Incontinence and other lower urinary tract symptoms (LUTS) 3)Quality of sleep 4) Quality of life 5) Sleep disturbance of partners 6)Safety. Patients will be asked to fill out questionnaires, diaries and to wear a wrist actiwatch for 2 weeks prior to starting melatonin and during the last 2 weeks of the 6 weeks treatment. A research nurse will telephone patients weekly whilst the patient is on Melatonin to enquire about medication use and any adverse events. After taking consent, the investigator will take a history covering urinary symptoms, and causes for nocturia, e.g. medications. Participants will be examined and severity of PD assessed using Hoehn and Yahr staging and UPDRS (Unified Parkinson's Disease Rating Scale). Height, weight and supine/standing blood pressure will be recorded. Urodynamics will be performed according to ICS Good Urodynamic Practice and will include uroflowmetry, bladder scan, filling cystometry and pressure flow study. This pilot study aims to evaluate any effect that melatonin may have on nocturia related bother in Parkinson's Disease. Chi square test will be used to analyse change in bother related to nocturia (primary outcome) and number of nocturia episodes and questionnaire scores (Secondary outcomes).

Conditions

• Parkinson's Disease
• Nocturia

Interventions

Type	Name	Description
DRUG	Melatonin	An open label clinical trial of sustained-release Melatonin 2mg once daily for 6 weeks.

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-09-01
• Completion: 2015-12-01
• First posted: 2015-02-10
• Last updated: 2015-02-10

Locations

1 site across 1 country: United Kingdom