Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness

Completed · Phase 2 · Has a placebo group

Conditions studied: Parkinson Disease

In brief

This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose levels of THN102 to placebo in patients suffering from Parkinson's disease associated with excessive daytime sleepiness.

Key facts

Study ID

NCT03624920

Run by

Theranexus

People needed

77

Starts

2018-07-12

Expected to finish

2020-02-24

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with a diagnosis of idiopathic Parkinson's disease as defined by the Movement Disorders Society (MDS).
• Subjects with Hoehn and Yahr scale score ≤ 4.
• Body mass index > 18 kg/m2 and < 35 kg/m2.
• Subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people).
• Epworth Sleepiness Scale (ESS) score ≥ 14.

You may not qualify if…

• Subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder.
• Psychiatric and neurological disorders (other than Parkinson's disease),
• Cardiovascular disorders such as - but not limited to
• Uncontrolled moderate to severe hypertension
• History or current diagnosis of electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study
• Recent myocardial infarction
• Stable or unstable angina pectoris
• Cardiac insufficiency or history of heart failure
• Previous history of cardiac valvular surgery
• Subjects with current impulse control disorder.
• Subjects showing dementia or with MoCA < 23.
• Subjects with current suicidal risk
• Current or recent (within one year) history of substance abuse or dependence disorder
• Other active clinically significant illness
• Subjects with hepatic or renal impairment

Where it is running

• University of Kansas Medical Center — Kansas City, Kansas, United States
• MGH Neurological Clinical Research Institute — Boston, Massachusetts, United States
• Houston Methodist Hospital — Houston, Texas, United States
• I. neurologická klinika Fakultní nemocnice u sv. Anny — Brno, Czechia
• Neurologická klinika Fakultní nemocnice Hradec Králové — Hradec Králové, Czechia
• Neurologická klinika Fakultní nemocnice Ostrava — Ostrava Poruba, Czechia
• Neurologická klinika 1.LF UK a VFN v Praze — Prague, Czechia
• NEURO - Praha, s.r.o. — Prague, Czechia
• Axon Clinical, s.r.o. — Prague, Czechia
• Neurologické oddělení Nemocnice Na Homolce — Prague, Czechia
• Institut neuropsychiatrické péče — Prague, Czechia
• Hôpital NEurologique Pierre Wertheimer — Bron, France
• CHRU Hopital Salengro — Lille, France
• CHU de la Timone Service de Neuro et pathologie du mouvement — Marseille, France
• CHRU Guy de Chauliac — Montpellier, France
• ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière — Paris, France
• CHU Charles Nicolle — Rouen, France
• CHU Purpan CIC Hall D 2eme etage — Toulouse, France
• Praxis Dr. Safavi, Neuroakademie Alzenau — Alzenau in Unterfranken, Germany
• Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin — Berlin, Germany
• Neurologische Praxis Dipl. med. Christian Oehlwein — Gera, Germany
• Pharmakologisches Studienzentrum Chemnitz — Mittweida, Germany
• Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum — München, Germany
• Praxis Dr. med. Arnfin Bergmann — Neuburg am Inn, Germany
• Neurozentrum Sophienstrasse — Stuttgart, Germany

Full record on ClinicalTrials.gov

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