None listed
Conditions
Interventions
Drug : Patients will receive opicapone 50 mg once daily at bedtime for 6 weeks.
Sponsors
Chungnam National University Sejong Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must provide written informed consent voluntarily, either personally or through a legally authorized representative. - If only the representative provides written consent due to the participant’s inability to do so, additional verbal consent from the participant is required, and documentation of this verbal consent must be maintained. 2. Male or female participants aged =20 years at the time of written consent. 3. Diagnosis of Parkinson’s disease (PD) according to the criteria of the International Parkinson and Movement Disorder Society. 4. Presence of nocturnal hypokinesia. - Defined as a score of =1 on Question 9 (nocturnal hypokinesia) of the Parkinson’s Disease Sleep Scale-2 (PDSS-2). 5. Hoehn and Yahr stage I–IV in the ON state. 6. Not currently taking levodopa preparations or other Parkinson’s disease medications at bedtime. 7. Stable use of levodopa preparations for at least 4 weeks prior to study participation. 8. Stable use of other Parkinson’s disease treatments for at least 4 weeks prior to study participation.
Exclusion criteria
Exclusion criteria: 1. Atypical or secondary parkinsonism. 2. Narcolepsy, excessive daytime sleep disorders, or sudden sleep onset. 3. History of dementia (Mini-Mental Status Examination [MMSE] = 20). 4. History of hallucinations or psychosis. 5. Contraindications to opicapone administration. 6. Any condition deemed by the investigator to interfere with study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Nocturnal Hypokinesia Questionnaire-Korean Version (NHQ-K) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PDSS-2 score at 6 weeks post-treatment;Change in MDS-UPDRS score at 6 weeks post-treatment;Change in PDQ-39 score at 6 weeks post-treatment;Change in NMSS score at 6 weeks post-treatment;Change in SCOPA-Sleep score at 6 weeks post-treatment;Change in SCOPA-Aut score at 6 weeks post-treatment;Change in QUIP score at 6 weeks post-treatment;Change in KESS score at 6 weeks post-treatment;Change in RBD-Q score at 6 weeks post-treatment;Change in FOG-Q score at 6 weeks post-treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactChaewon Shin
Seoul National University Bundang Hospital
Outcome results
None listed