Parkinson Disease
Conditions
Brief summary
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.
Detailed description
This is a multi-center, open-label, single-arm 8-week investigation of Selegiline. Subjects who have a diagnosis of PD based on UK brain bank criteria with ESS\> 7 will be received Selegiline as an adjunctive therapy or monotherapy. This study will assess the impact of Selegiline treatment on the severity of sleep disturbances among PD patients.
Interventions
DRUGSelegiline
Subjects will receive one Selegiline tablet (5 mg) per day administered at breakfast. The initial dose of Selegiline is 5 mg/day and be up-titrated in 2-week intervals in increments of 5 mg up to 10 mg (which can be taken at breakfast or divided doses of 5 mg each taken at breakfast and lunch) according to the investigator's judgment, based on individual clinical response and tolerability.
Sponsors
Second Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female and greater from 30 to 80. 2. Diagnosis of idiopathic PD according to the UK Brain Bank criteria. 3. Epworth Sleepiness Scale (ESS) \>7. 4. Stable dose of anti-Parkinson drugs for at least 30 days. 5. No use of MAO-B inhibitors within the preceding 4 weeks. 6. No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.
Exclusion criteria
1. Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism. 2. Shift-work, which cannot ensure a stable sleep-wake cycle habits. 3. History of contraindications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean change of ESS score will be assessed from baseline to 8 weeks when given Selegiline as an adjunctive therapy or monotherapy in PD patients with daytime sleepiness. | 8 weeks | This outcome was used to assess relationships among changes in ESS from baseline to the endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment. | 8 weeks | This outcome corresponds to the number of patients with daytime sleepiness. |
| The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment. | 8 weeks | This outcome reflects change of patients'daily quality. |
| The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment. | 8 weeks | This outcome corresponds to motor complications. |
Countries
China
Outcome results
None listed