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Melatonin for Nocturia in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Nocturia

Status

Unknown status

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Melatonin

About this trial

This is an interventional treatment trial for Parkinson's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
Patients with rare hereditary problems of galactose intolerance, the LAP lactose deficiency or galactose malabsorption
Excessive alcohol consumption as defined by the investigator

Sites / Locations

National Hospital for Neurology and Neurosurgery and UCL Institute of Neurology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Melatonin

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

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

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

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

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

Full Information

NCT ID

NCT02359448

First Posted

February 4, 2015

Last Updated

February 4, 2015

Sponsor

University College, London

1. Study Identification

Unique Protocol Identification Number

NCT02359448

Brief Title

Melatonin for Nocturia in Parkinson's Disease

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

April 2015 (undefined)

Primary Completion Date

September 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease, Nocturia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Melatonin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Melatonin

Other Intervention Name(s)

Circadin

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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).

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 Patients with rare hereditary problems of galactose intolerance, the LAP lactose deficiency or galactose malabsorption Excessive alcohol consumption as defined by the investigator

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adedayo Akinyemi

a.akinyemi@ucl.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jalesh Panicker

Organizational Affiliation

UCL

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Hospital for Neurology and Neurosurgery and UCL Institute of Neurology

City

London

ZIP/Postal Code

WC1N 3BG

Country

United Kingdom

12. IPD Sharing Statement

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Melatonin for Nocturia in Parkinson's Disease

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