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

NCT ID: NCT03624920

Last Updated: 2020-12-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-12

Study Completion Date

2020-02-24

Brief Summary

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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

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

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Complete 3 way-Crossover
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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THN102 Dosage A

THN102 Dosage A is a Placebo

Group Type PLACEBO_COMPARATOR

THN102 Dosage A

Intervention Type DRUG

THN102 Dosages A: placebo

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

Group Type EXPERIMENTAL

THN102 Dosage B

Intervention Type DRUG

THN102 Dosage B : 200mg/2mg

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

Group Type EXPERIMENTAL

THN102 Dosage C

Intervention Type DRUG

THN102 Dosage C: 200mg/18mg

Interventions

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THN102 Dosage A

THN102 Dosages A: placebo

Intervention Type DRUG

THN102 Dosage B

THN102 Dosage B : 200mg/2mg

Intervention Type DRUG

THN102 Dosage C

THN102 Dosage C: 200mg/18mg

Intervention Type DRUG

Other Intervention Names

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Placebo Dosage B Dosage C

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theranexus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Christophe Corvol, Prof

Role: STUDY_CHAIR

Hôpital La Pitié-Salpêtrière, 75651 Paris, France, Tel. +33 1 42 16 57 66, mail: [email protected]

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

MGH Neurological Clinical Research Institute

Boston, Massachusetts, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

I. neurologická klinika Fakultní nemocnice u sv. Anny

Brno, , Czechia

Site Status

Neurologická klinika Fakultní nemocnice Hradec Králové

Hradec Králové, , Czechia

Site Status

Neurologická klinika Fakultní nemocnice Ostrava

Ostrava Poruba, , Czechia

Site Status

Neurologická klinika 1.LF UK a VFN v Praze

Prague, , Czechia

Site Status

NEURO - Praha, s.r.o.

Prague, , Czechia

Site Status

Axon Clinical, s.r.o.

Prague, , Czechia

Site Status

Neurologické oddělení Nemocnice Na Homolce

Prague, , Czechia

Site Status

Institut neuropsychiatrické péče

Prague, , Czechia

Site Status

Hôpital NEurologique Pierre Wertheimer

Bron, , France

Site Status

CHRU Hopital Salengro

Lille, , France

Site Status

CHU de la Timone Service de Neuro et pathologie du mouvement

Marseille, , France

Site Status

CHRU Guy de Chauliac

Montpellier, , France

Site Status

ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière

Paris, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

CHU Purpan CIC Hall D 2eme etage

Toulouse, , France

Site Status

Praxis Dr. Safavi, Neuroakademie Alzenau

Alzenau in Unterfranken, , Germany

Site Status

Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin

Berlin, , Germany

Site Status

Neurologische Praxis Dipl. med. Christian Oehlwein

Gera, , Germany

Site Status

Pharmakologisches Studienzentrum Chemnitz

Mittweida, , Germany

Site Status

Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum

München, , Germany

Site Status

Praxis Dr. med. Arnfin Bergmann

Neuburg am Inn, , Germany

Site Status

Neurozentrum Sophienstrasse

Stuttgart, , Germany

Site Status

NeuroPoint

Ulm, , Germany

Site Status

Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:

Westerstede, , Germany

Site Status

Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály

Budapest, , Hungary

Site Status

Észak-Közép-budai Centrum

Budapest, , Hungary

Site Status

Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály

Debrecen, , Hungary

Site Status

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály

Miskolc, , Hungary

Site Status

PTE KK Neurológiai Klinika

Pécs, , Hungary

Site Status

Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika

Szeged, , Hungary

Site Status

Theranexus Investigational site

Szeged, , Hungary

Site Status

Countries

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United States Czechia France Germany Hungary

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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THN102-202

Identifier Type: -

Identifier Source: org_study_id