Clinical trial NCT03624920: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Official title: Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Lead sponsor: Theranexus
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Complete 3 way-Crossover
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week washout period.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety Adverse Events
timeFrame: 2 weeks
Secondary outcomes:
measure: Epworth Sleeping Scale (ESS)
timeFrame: 2 weeks
measure: Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline
timeFrame: 2 weeks
measure: Montreal Cognitive Assessment Battery (MoCA)
timeFrame: 2 weeks
measure: Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline
timeFrame: 2 weeks
measure: Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: MGH Neurological Clinical Research Institute
state: Massachusetts
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Brno
country: Czechia
facility: I. neurologická klinika Fakultní nemocnice u sv. Anny
city: Hradec Králové
country: Czechia
facility: Neurologická klinika Fakultní nemocnice Hradec Králové
city: Ostrava Poruba
country: Czechia
facility: Neurologická klinika Fakultní nemocnice Ostrava
city: Praga 8
country: Czechia
facility: Institut neuropsychiatrické péče
city: Praha 2
country: Czechia
facility: Neurologická klinika 1.LF UK a VFN v Praze
city: Praha 4
country: Czechia
facility: NEURO - Praha, s.r.o.
city: Praha 5
country: Czechia
facility: Axon Clinical, s.r.o.
city: Praha 5
country: Czechia
facility: Neurologické oddělení Nemocnice Na Homolce
city: Bron
country: France
facility: Hôpital NEurologique Pierre Wertheimer
city: Lille
country: France
facility: CHRU Hopital Salengro
city: Marseille
country: France
facility: CHU de la Timone Service de Neuro et pathologie du mouvement
city: Montpellier
country: France
facility: CHRU Guy de Chauliac
city: Paris
country: France
facility: ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière
city: Rouen
country: France
facility: CHU Charles Nicolle
city: Toulouse
country: France
facility: CHU Purpan CIC Hall D 2eme etage
city: Alzenau In Unterfranken
country: Germany
facility: Praxis Dr. Safavi, Neuroakademie Alzenau
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin
city: Gera
country: Germany
facility: Neurologische Praxis Dipl. med. Christian Oehlwein
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz
city: München
country: Germany
facility: Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum
city: Neuburg
country: Germany
facility: Praxis Dr. med. Arnfin Bergmann
city: Stuttgart
country: Germany
facility: Neurozentrum Sophienstrasse
city: Ulm
country: Germany
facility: NeuroPoint
city: Westerstede
country: Germany
facility: Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:
city: Budapest
country: Hungary
facility: Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály
city: Budapest
country: Hungary
facility: Észak-Közép-budai Centrum
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály
city: Pécs
country: Hungary
facility: PTE KK Neurológiai Klinika
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika
city: Szeged
country: Hungary
facility: Theranexus Investigational site
Study officials:
affiliation: Hôpital La Pitié-Salpêtrière, 75651 Paris, France, Tel. +33 1 42 16 57 66, mail: jean-christophe.corvol@aphp.fr
name: Jean-Christophe Corvol, Prof
role: STUDY_CHAIR
References: