Trials / Completed
CompletedNCT03255642
Efficacy and Safety of Melatonin and Clonazepam for IRBD
Efficacy and Safety of Melatonin and Rivotril Treatment for Idiopathic Rapid Eye Movement Sleep Disorder: Prospective Randomized Study.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Kyung Hee University Hospital at Gangdong · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study aimed to evaluate influence of melatonin or clonazepam treatment on symptom and polysomnographic parameters in patients with idiopathic REM sleep behavior disorder.
Detailed description
This study is open-label parallel trial with 4 weeks treatment with slow-release melatonin (Circadin) or with clonazepam (Rivotril). Polysomnography, symptom diary and questionnaire (Clinical Global Impression, RBDQ-HK, PSQI, ESS, SSS, ISI, BDI-II) will be performed before and after 4 weeks of each medications.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Melatonin 2mg | 4 weeks of 2mg prolonged release melatonin (Circadin) |
| DRUG | ClonazePAM 0.5 MG | 4 weeks of 0.5mg clonazepam (Rivotril) |
Timeline
- Start date
- 2017-11-09
- Primary completion
- 2020-12-01
- Completion
- 2020-12-01
- First posted
- 2017-08-21
- Last updated
- 2021-02-21
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03255642. Inclusion in this directory is not an endorsement.