Melatonin for Nocturia in Parkinson's Disease

NCT02359448 | Unknown Phase 2 DMC

• 1 other identifier: 14/0382
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Parkinson's Disease; Nocturia

Outcome Measures

Primary Outcomes (1)

• Change in bother related to nocturia as measured by a standardised validated questionnaire(ICIQ-N)

  The primary outcome of this study is improvement on bother related to nocturia, as measured by the International Consultation on Incontinence Questionnaire Nocturia Module (ICIQ-N).

  6 weeks

Secondary Outcomes (5)

• Improvement in mean night time urinary frequency assessed from the frequency volume chart and a standardised validated questionnaire(ICIQ-N)

  6 weeks

• Improvement in the Nocturnal polyuria index, percentage of volume of urine voided at night, calculated from the frequency volume chart.

  6 weeks

• Improvement in overall lower urinary tract symptoms (LUTS), assessed by standardised validated questionnaires, ie. Urinary Symptom Profile

  6 weeks

• Improvement on sleep disturbances, assessed using a standardised validated questionnaire, Pittsburgh Sleep Quality Index, sleep diary and Actigraphy

  6 weeks

• Sleep disturbance in partners/careers assessed by sleep diary and Pittsburgh Sleep Quality Index

  6 weeks

Study Arms (1)

Melatonin

EXPERIMENTAL

Patients will be prescribed and dispensed from pharmacy sustained -release Melatonin (Circadin) 2mg. This will be taken every night for twelve weeks.

Drug: Melatonin

Interventions

Melatonin DRUG

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

Also known as: Circadin

Melatonin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults male and female(\> 18 years) with clinically diagnosed PD according to the Brain Bank Criteria
• Reporting nocturia to NMSQuest item 9 -"Getting up regularly at night to pass urine" and getting up to pass urine two or more times at night. Although the International Continence Society (ICS) defines nocturia as waking up at night one or more times to void, a recent population based study has shown that two voids or more is associated with bother and impaired health related quality of life.
• Able to provide informed written consent

You may not qualify if:

• Montreal Cognitive Assessment (MOCA) score \< 26
• History suggestive of REM sleep behaviour disorder
• Congestive heart failure, liver failure or kidney failure as determined by medical history
• Uncontrolled diabetes, or significant microalbuminuria in patients with diabetes
• Using medications such as benzodiazepines and Z-drugs (e.g. Zaleplon, Zolpidem and Zopiclone)
• Presence of urinary tract infection as determined by the clinician
• Evidence for incomplete bladder emptying, i.e., post void residual urine of more than 100 mL as determined by ultrasound (bladder scan)
• Presence of significantly enlarged prostate as determined by the clinician using the European Association of Urology (EAU) guidelines based on urodynamic findings
• Females of childbearing potential must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
• Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for trial treatment.
• Females must not be breastfeeding.
• Allergies to excipients of IMP
• Smokers
• Patient with autoimmune disease
• Patients taking carbamazepine, rifampicin and cimetidine

Sponsors & Collaborators

• University College, London: lead

Study Sites (1)

National Hospital for Neurology and Neurosurgery and UCL Institute of Neurology

London, WC1N 3BG, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Nocturia

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jalesh Panicker

  UCL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adedayo Akinyemi

CONTACT

a.akinyemi@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 10, 2015
• Study Start: April 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

GB (1)