Parkinson's DiseasePhase 2NCT02359448
Melatonin for Nocturia in Parkinson's Disease
A Phase 2 study testing Melatonin in people with Parkinson's Disease and Nocturia, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Nocturia
- What is being tested?
- Melatonin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Adedayo Akinyemi contact
United Kingdom1 site
National Hospital for Neurology and Neurosurgery and UCL Institute of Neurology
London, WC1N 3BG
About this study
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
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
Read the 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
- Being tested
- Melatonin
- Medical subject headings
- Parkinson Disease, Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Circadin
An open label clinical trial of sustained-release Melatonin 2mg once daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Experimental | Patients will be prescribed and dispensed from pharmacy sustained -release Melatonin (Circadin) 2mg. This will be taken every night for twelve weeks. Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 6 weeks
Improvement in the Nocturnal polyuria index, percentage of volume of urine voided at night, calculated from the frequency volume chart.
Measured: 6 weeks
Improvement in overall lower urinary tract symptoms (LUTS), assessed by standardised validated questionnaires, ie. Urinary Symptom Profile
Measured: 6 weeks
Improvement on sleep disturbances, assessed using a standardised validated questionnaire, Pittsburgh Sleep Quality Index, sleep diary and Actigraphy
Measured: 6 weeks
Sleep disturbance in partners/careers assessed by sleep diary and Pittsburgh Sleep Quality Index
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startApr 2015
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jalesh Panicker, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359448
- Sponsor's protocol ID
- 14/0382
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 10 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02359448
- Acronym / sponsor ID
- 14/0382
- Conditions
- Parkinson's Disease, Nocturia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Experimental | Drug: MelatoninPatients will be prescribed and dispensed from pharmacy sustained -release Melatonin (Circadin) 2mg. This will be taken every night for twelve weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: CircadinAn open label clinical trial of sustained-release Melatonin 2mg once daily for 6 weeks. | Drug | Melatonin |
Primary outcome
Change in bother related to nocturia as measured by a standardised validated questionnaire(ICIQ-N)
Time frame: 6 weeks
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).
5 secondary outcomes
Improvement in mean night time urinary frequency assessed from the frequency volume chart and a standardised validated questionnaire(ICIQ-N)
Time frame: 6 weeks
Improvement in the Nocturnal polyuria index, percentage of volume of urine voided at night, calculated from the frequency volume chart.
Time frame: 6 weeks
Improvement in overall lower urinary tract symptoms (LUTS), assessed by standardised validated questionnaires, ie. Urinary Symptom Profile
Time frame: 6 weeks
Improvement on sleep disturbances, assessed using a standardised validated questionnaire, Pittsburgh Sleep Quality Index, sleep diary and Actigraphy
Time frame: 6 weeks
Sleep disturbance in partners/careers assessed by sleep diary and Pittsburgh Sleep Quality Index
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adedayo Akinyemi contact
Jalesh Panicker principal investigator
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin in people with Parkinson's Disease and Nocturia, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adedayo Akinyemi (a.akinyemi@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bother related to nocturia as measured by a standardised validated questionnaire(ICIQ-N) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2015.