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The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease

The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000019676
Enrollment
20
Registered
2015-11-10
Start date
2015-11-10
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson&#39

Interventions

taking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks taking matching placebo after breakfast for 4 weeks, wash out for

Sponsors

Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1: Patients with parkinson' disease 2: ESS total score >=8

Exclusion criteria

Exclusion criteria: 1 : Patient who can not take orally. 2 : Patient with severe arrhythmia. 3 : Pregnant women and lactating patient 4 : Patient can not answer a questionnaire about excessive daytime sleepiness. 5 : Patient can not make regular clinic visits. 6 : Patient have methylphenidate or/and Pemoline. 7 : Patient is difficult to express one's agreement.

Design outcomes

Primary

MeasureTime frame
change of the Epworth Sleepiness Scale score—

Secondary

MeasureTime frame
change of UPDRS part2 and 3 score, Mini Mental State Examination score, basic rhythm of brain waves and evaluation of caregivers—

Countries

Japan

Contacts

Public ContactRina Ando

Ehime University Graduate School of Medicine Neurology and Clinical Pharmacology

ando.rina.cn@ehime-u.ac.jp089-960-5095

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026