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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Selegiline
Sponsored by
Second Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Selegiline

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 15, 2020
Last Updated
May 5, 2021
Sponsor
Second Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT04870372
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Selegiline
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Selegiline
Other Intervention Name(s)
ELDEPRYL
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The proportion of patients with daytime sleepiness (ESS> 7) will be evaluated at the baseline and after 8 weeks treatment.
Description
This outcome corresponds to the number of patients with daytime sleepiness.
Time Frame
8 weeks
Title
The mean change of PDQ-8 scores will be assessed from baseline to 8 weeks of treatment.
Description
This outcome reflects change of patients'daily quality.
Time Frame
8 weeks
Title
The mean change of UPDRS IV items 32 and 39 scores will be assessed from baseline to 8 weeks of treatment.
Description
This outcome corresponds to motor complications.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-feng Liu, MD,PhD
Organizational Affiliation
Second Affiliated Hospital of Soochow University
Official's Role
Study Chair
Facility Information:
Facility Name
Changshu Hospital Affiliated to Nanjing University of Chinese Medicine
City
Changshu
State/Province
Jiangsu
Country
China
Facility Name
Second Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
Country
China
Facility Name
Department of Neurology, Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Facility Name
Jiang Yuan Hospital Affiliated to Jiangsu Institute of Nuclear Medicine
City
Wuxi
State/Province
Jiangsu
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26085603
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.
Results Reference
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PubMed Identifier
27827298
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.
Results Reference
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Selegiline for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease

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