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

May 5, 2021 updated by: Second Affiliated Hospital of Soochow University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

141

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changshu, Jiangsu, China
        • Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
      • Nantong, Jiangsu, China
        • Second Affiliated Hospital of Nantong University
      • Suzhou, Jiangsu, China, 215004
        • Department of Neurology, Second Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China
        • Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Selegiline
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
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.
Other Names:
  • ELDEPRYL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 8 weeks
This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.
Time Frame: 8 weeks
This outcome corresponds to the number of patients with daytime sleepiness.
8 weeks
The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.
Time Frame: 8 weeks
This outcome reflects change of patients'daily quality.
8 weeks
The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.
Time Frame: 8 weeks
This outcome corresponds to motor complications.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Investigators

  • Study Chair: Chun-feng Liu, MD,PhD, Second Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2020

Primary Completion (ACTUAL)

December 31, 2020

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

April 28, 2021

First Posted (ACTUAL)

May 3, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 7, 2021

Last Update Submitted That Met QC Criteria

May 5, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JD-LK-2019-103-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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