Clinical trial NCT04870372: Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
Official title: A Multi-center, Open-Label Study to Evaluate the Efficacy and Safety of Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson Disease
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 141
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 8 weeks
Secondary outcomes:
measure: The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.
timeFrame: 8 weeks
measure: The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.
timeFrame: 8 weeks
measure: The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Changshu
country: China
facility: Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
state: Jiangsu
city: Nantong
country: China
facility: Second Affiliated Hospital of Nantong University
state: Jiangsu
city: Suzhou
country: China
facility: Department of Neurology, Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine
state: Jiangsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Chun-feng Liu, MD,PhD
role: STUDY_CHAIR
References:
citation: Tholfsen LK, Larsen JP, Schulz J, Tysnes OB, Gjerstad MD. Development of excessive daytime sleepiness in early Parkinson disease. Neurology. 2015 Jul 14;85(2):162-8. doi: 10.1212/WNL.0000000000001737. Epub 2015 Jun 17.
citation: Panisset M, Stril JL, Belanger M, Lehoux G, Coffin D, Chouinard S. Open-Label Study of Sleep Disturbances in Patients with Parkinson's Disease Treated with Rasagiline. Can J Neurol Sci. 2016 Nov;43(6):809-814. doi: 10.1017/cjn.2016.289.