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

Status: Completed
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

• 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.

Locations
United States
Kansas
University of Kansas Medical Center
Kansas City
Massachusetts
MGH Neurological Clinical Research Institute
Boston
Texas
Houston Methodist Hospital
Houston
Other Locations
France
Hôpital NEurologique Pierre Wertheimer
Bron
CHRU Hopital Salengro
Lille
CHU de la Timone Service de Neuro et pathologie du mouvement
Marseille
CHRU Guy de Chauliac
Montpellier
ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière
Paris
CHU Charles Nicolle
Rouen
CHU Purpan CIC Hall D 2eme etage
Toulouse
Germany
Praxis Dr. Safavi, Neuroakademie Alzenau
Alzenau In Unterfranken
Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin
Berlin
Neurologische Praxis Dipl. med. Christian Oehlwein
Gera
Pharmakologisches Studienzentrum Chemnitz
Mittweida
Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum
München
Praxis Dr. med. Arnfin Bergmann
Neuburg
Neurozentrum Sophienstrasse
Stuttgart
NeuroPoint
Ulm
Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:
Westerstede
Hungary
Észak-Közép-budai Centrum
Budapest
Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály
Budapest
Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály
Debrecen
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály
Miskolc
PTE KK Neurológiai Klinika
Pécs
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika
Szeged
Theranexus Investigational site
Szeged
Time Frame
Start Date: July 12, 2018
Completion Date: February 24, 2020
Participants
Target number of participants: 77
Treatments
Placebo Comparator: THN102 Dosage A
THN102 Dosage A is a Placebo
Experimental: THN102 Dosage B
THN102 Dosage B : 200 mg/2 mg THN102 is a combination of modafinil 100mg and flecainide 1 mg daily dosage is 200 mg of modafinil and 2 mg of flecainide
Experimental: THN102 Dosage C
THN102 Dosage C : 200 mg/18 mg THN102 is a combination of modafinil 100mg and flecainide 9 mg daily dosage is 200 mg of modafinil and 18 mg of flecainide
Authors
Jan PEREGRIN, Julianna LAJTOS, Magdonlna BOKOR, Rajesh Pahwa, Olga WALN, Jindra Svátová, Kateřina Zárubová, Daniela RAU, Ali SAFAVI, David MALTETE, Arnfin BERGMANN, Fabian KLOSTERMANN, Luc DEFEBVRE, Ralf BODENSCHATZ, Olivier RASCOL, Stéphane THOBOIS, Heinz-Peter HERBST, Yves DAUVILLIERS, Christian OEHLWEIN, Joachim SPRINGUB, Paul LINGOR, Pavel RESSNER, Attila VALIKOVICS, Hana Brožová, Ondřej Fiala, Jean-Philippe AZULAY, Martin Vališ, László Vécsei, Marek Baláž, Norbert KOVACS
Sponsors
Leads: Theranexus

This content was sourced from clinicaltrials.gov

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