Trials / Unknown
UnknownNCT02768077
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease
Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled Trial
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Kuhnil Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
This clinical study is a double-blind, randomized, placebo-controlled trial to investigate the effects of melatonin on the sleep disturbance symptoms of Parkinson's disease patients, symptoms which have a significant impact on the quality of life of these patients.
Detailed description
After selecting patients who satisfied the inclusion criteria and were not disqualified by the exclusion criteria, through a double-blind procedure the patients are directed to orally take either the investigational drug melatonin or a placebo(allocation ratio 1:1) for 4 weeks, once daily, before going to sleep. The evaluation of efficacy and safety is performed at the first baseline and immediately after administering the drug for 4 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Melatonin(Circadin®) | |
| DRUG | Placebo |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-02-01
- Completion
- 2017-02-01
- First posted
- 2016-05-11
- Last updated
- 2016-05-18
Source: ClinicalTrials.gov record NCT02768077. Inclusion in this directory is not an endorsement.