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Completed

NCT Number: NCT04870372

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Changshu Hospital Affiliated to Nanjing University of Chinese Medicine, Changshu, Jiangsu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ELDEPRYL

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.

    Time frame: 8 weeks

    This outcome was used to assess relationships among changes in ESS from baseline to the endpoint.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Soochow University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 3, 2021
Registry last updated
May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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