Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04870372
• Other study ID #: JD-LK-2019-103-02
• Status: Completed
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: May 2021
• Source: Second Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open-label, single-arm 8-week investigation of Selegiline for treatment of EDS in PD patients.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 30, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Sleepiness

Intervention

Drug:
• Selegiline
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.

Locations

Country	Name	City	State
China	Changshu Hospital Affiliated to Nanjing University of Chinese Medicine	Changshu	Jiangsu
China	Second Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Department of Neurology, Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine	Wuxi	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (2)

Panisset M, Stril JL, Bélanger 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.	8 weeks
Secondary	The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.	This outcome corresponds to the number of patients with daytime sleepiness.	8 weeks
Secondary	The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.	This outcome reflects change of patients'daily quality.	8 weeks
Secondary	The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.	This outcome corresponds to motor complications.	8 weeks