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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Patients will be prescribed and dispensed from pharmacy sustained -release Melatonin (Circadin) 2mg. This will be taken every night for twelve weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | An open label clinical trial of sustained-release Melatonin 2mg once daily for 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adedayo Akinyemi | Contact | a.akinyemi@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Jalesh Panicker | UCL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hospital for Neurology and Neurosurgery and UCL Institute of Neurology | London | WC1N 3BG | United Kingdom |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D053158 | Nocturia |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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 |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |