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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02359448 |
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Date of registration:
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04/02/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Melatonin for Nocturia in Parkinson's Disease
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Scientific title:
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Single-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's Disease |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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20 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02359448 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Jalesh Panicker |
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Address:
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Telephone:
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Email:
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Affiliation:
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UCL |
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Name:
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Adedayo Akinyemi |
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Address:
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Telephone:
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Email:
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a.akinyemi@ucl.ac.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Adults male and female(> 18 years) with clinically diagnosed PD according to the
Brain Bank Criteria
2. 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.
3. Able to provide informed written consent
Exclusion Criteria:
1. Montreal Cognitive Assessment (MOCA) score < 26
2. History suggestive of REM sleep behaviour disorder
3. Congestive heart failure, liver failure or kidney failure as determined by medical
history
4. Uncontrolled diabetes, or significant microalbuminuria in patients with diabetes
5. Using medications such as benzodiazepines and Z-drugs (e.g. Zaleplon, Zolpidem and
Zopiclone)
6. Presence of urinary tract infection as determined by the clinician
7. Evidence for incomplete bladder emptying, i.e., post void residual urine of more than
100 mL as determined by ultrasound (bladder scan)
8. Presence of significantly enlarged prostate as determined by the clinician using the
European Association of Urology (EAU) guidelines based on urodynamic findings
9. 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.
10. Females of childbearing potential must have a negative pregnancy test within 7 days
prior to being registered for trial treatment.
11. Females must not be breastfeeding.
12. Allergies to excipients of IMP
13. Smokers
14. Patient with autoimmune disease
15. Patients taking carbamazepine, rifampicin and cimetidine
16. Patients with rare hereditary problems of galactose intolerance, the LAP lactose
deficiency or galactose malabsorption
17. Excessive alcohol consumption as defined by the investigator
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nocturia
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Parkinson's Disease
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Intervention(s)
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Drug: Melatonin
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Primary Outcome(s)
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Change in bother related to nocturia as measured by a standardised validated questionnaire(ICIQ-N)
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Improvement in mean night time urinary frequency assessed from the frequency volume chart and a standardised validated questionnaire(ICIQ-N)
[Time Frame: 6 weeks]
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Improvement in overall lower urinary tract symptoms (LUTS), assessed by standardised validated questionnaires, ie. Urinary Symptom Profile
[Time Frame: 6 weeks]
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Improvement on sleep disturbances, assessed using a standardised validated questionnaire, Pittsburgh Sleep Quality Index, sleep diary and Actigraphy
[Time Frame: 6 weeks]
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Improvement in the Nocturnal polyuria index, percentage of volume of urine voided at night, calculated from the frequency volume chart.
[Time Frame: 6 weeks]
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Sleep disturbance in partners/careers assessed by sleep diary and Pittsburgh Sleep Quality Index
[Time Frame: 6 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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