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

NCT04870372 | Completed Phase 4

• 1 other identifier: JD-LK-2019-103-02
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.

  8 weeks

• The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.

  8 weeks

• The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.

  8 weeks

Study Arms (1)

Selegiline

EXPERIMENTAL

Subjects who meet all of the inclusion and none of the exclusion criteria will be received Selegiline.The study medication dosage will be escalated from 5mg/daily to the target dose(5\~10mg/daily) in 2 weeks and then maintained for the remaining 6 weeks.

Drug: Selegiline

Interventions

Selegiline DRUG

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.

Also known as: ELDEPRYL

Selegiline

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female and greater from 30 to 80.
• Diagnosis of idiopathic PD according to the UK Brain Bank criteria.
• Epworth Sleepiness Scale (ESS) \>7.
• Stable dose of anti-Parkinson drugs for at least 30 days.
• No use of MAO-B inhibitors within the preceding 4 weeks.
• No cognitive impairment, defined by Mini-Mental State Exam score ≤ 26.

You may not qualify if:

• Diagnosis of atypical Parkinsonian syndrome, vascular Parkinsonism or drug-induced Parkinsonism.
• Shift-work, which cannot ensure a stable sleep-wake cycle habits.
• History of contraindications.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (4)

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine

Changshu, Jiangsu, China

Location

Second Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Location

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine

Wuxi, Jiangsu, China

Location

Related Publications (2)

• 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.

  PMID: 26085603 BACKGROUND

• 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.

  PMID: 27827298 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Interventions

Selegiline

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Chun-feng Liu, MD,PhD

  Second Affiliated Hospital of Soochow University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: May 3, 2021
• Study Start: March 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: April 30, 2021
• Last Updated: May 7, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)