CompletedPhase 2ACTRN12613000648729

Efficacy of melatonin in rapid eye movement (REM sleep) behaviour disorder with coexisting Parkinsonism

Efficacy of melatonin in rapid eye movement (REM) sleep behaviour disorder with coexisting Parkinsonism: A double-blind, randomised controlled trial

Sponsor

The Woolcock Institute of Medical Research

Enrollment

30 participants

Start Date

Aug 1, 2013

Study Type

Interventional

Conditions

REM sleep behaviour disorder Efficacy of melatonin Parkinsonism

Summary

The primary aim of the study is to test in a randomised, double blind, placebo controlled trial the efficacy of melatonin in patients with REM sleep behaviour disorder over 8 weeks of treatment Specifically, we will test the hypothesis that, compared to placebo, melatonin treatment will result in a reduction in the frequency of patients' self reported events

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria6

Age over 18
MiniMental State Examination>/=24
REM sleep Behaviour Disorde (RBD)r as defined by the International Classification for Sleep Disorder criteria (ICSD-2)
Screening questionnaire criteria (RBDSQ) with a score equal or greater than 5/13 confirmed by bed partner
Two or more events of RBD defined by dream enactment behaviour and/or sleep related injuries (question 2 and 4 of the wCIRUS-RBDQ) during the 4 weeks (screening period) prior to randomisation.
Stable medications for 1 month prior to randomisation.

Exclusion Criteria9

Untreated Obstructive sleep apnea with Apnea Hypopnea Index >20
Significant psychiatric disorder or cognitive impairment (MMSE< 24)
Any significant liver, kidney or autoimmune disease.
Current use of benzodiazepines or other non-benzodiazepine hypnotics (e.g. zaleplon, zolpidem, zopiclone), native compounds of melatonin, other melatoninergic agonists,, unless washout of more than four weeks
Drug-induced RBD (antidepressants) with clear relation between RBD onset and medication
Excessive alcohol consumption (>25 Unit/week)
Pregnancy or lactation
Use of light therapy (for treatment of sleep-wake disorders) within the last 6 months
Galactose intolerance, LAPP lactase deficiency or glucose-galactose malabsorption

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Interventions

Circadin prolonged release tablet 2 mg (prolonged release melatonin 2mg) - 1x2tablets (total of 4mg per day) , orally ingested , after food, within 1 hour bedtime for 8 weeks Total duration of the tr

Circadin prolonged release tablet 2 mg (prolonged release melatonin 2mg) - 1x2tablets (total of 4mg per day) , orally ingested , after food, within 1 hour bedtime for 8 weeks Total duration of the trial is 16 weeks: 4 weeks of screening period, 8 weeks of treatment period, 4 weeks of followup period.