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

Phase 2

Completed

• Conditions: Parkinson Disease
• Interventions: Drug: THN102 Dosage A; Drug: THN102 Dosage B; Drug: THN102 Dosage C

• Registration Number: NCT03624920
• Lead Sponsor: Theranexus

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.

Study Timeline

• Study First Submitted: 2018-07-10
• Study Start: 2018-07-12
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Primary Completion: 2019-12-20
• Study Completion: 2020-02-24
• Results First Submitted: 2020-09-27
• Status Verified: 2020-10
• Results First Submitted QC: 2020-11-27
• Last Update Submitted: 2020-11-27
• Results First Posted: 2020-12-01
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
THN102 Dosage A	THN102 Dosage A	THN102 Dosage A is a Placebo
THN102 Dosage B	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
THN102 Dosage C	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

Primary Outcome Measures

Name	Time	Method
Safety Adverse Events	2 weeks	Number of participants with spontaneously reported treatment-related adverse events

Secondary Outcome Measures

Name	Time	Method
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline	2 weeks	PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.
Epworth Sleeping Scale (ESS)	2 weeks	Range of the scale : 0 to 24. A low score indicates a good outcome. Results shown are corresponding to a change from baseline of the ESS score.
Montreal Cognitive Assessment Battery (MoCA)	2 weeks	MoCA score reflects the cognitive capacities of a person. Range of the total score of 10 test items: 0 to 30 points. A high score indicates good cognitive functioning. A score of 26 and above is considered normal.; The results below are shown as change from baseline of the MoCA score.
Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline	2 weeks	Number of patients in remission (=without residual sleepiness), i.e. ESS \< 11 at the end of each treatment period
Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline	2 weeks	ESS score responder rate, defined as the proportion of subjects with at least 25% ESS improvement from baseline, at the end of each treatment period

Trial Locations

Locations (34)

MGH Neurological Clinical Research Institute; 🇺🇸 Boston, Massachusetts, United States

Institut neuropsychiatrické péče; 🇨🇿 Praga 8, Czechia

Axon Clinical, s.r.o.; 🇨🇿 Praha 5, Czechia

Neurologické oddělení Nemocnice Na Homolce; 🇨🇿 Praha 5, Czechia

Hôpital NEurologique Pierre Wertheimer; 🇫🇷 Bron, France

CHU Charles Nicolle; 🇫🇷 Rouen, France

Neurologická klinika Fakultní nemocnice Ostrava; 🇨🇿 Ostrava Poruba, Czechia

Praxis Dr. Safavi, Neuroakademie Alzenau; 🇩🇪 Alzenau In Unterfranken, Germany

CHRU Hopital Salengro; 🇫🇷 Lille, France

Neurozentrum Sophienstrasse; 🇩🇪 Stuttgart, Germany

Neurologická klinika 1.LF UK a VFN v Praze; 🇨🇿 Praha 2, Czechia

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States

Praxis Dr. med. Arnfin Bergmann; 🇩🇪 Neuburg, Germany

Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika; 🇭🇺 Szeged, Hungary

NEURO - Praha, s.r.o.; 🇨🇿 Praha 4, Czechia

CHU Purpan CIC Hall D 2eme etage; 🇫🇷 Toulouse, France

PTE KK Neurológiai Klinika; 🇭🇺 Pécs, Hungary

Theranexus Investigational site; 🇭🇺 Szeged, Hungary

Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály; 🇭🇺 Debrecen, Hungary

Észak-Közép-budai Centrum; 🇭🇺 Budapest, Hungary

NeuroPoint; 🇩🇪 Ulm, Germany

CHU de la Timone Service de Neuro et pathologie du mouvement; 🇫🇷 Marseille, France

ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière; 🇫🇷 Paris, France

Neurologická klinika Fakultní nemocnice Hradec Králové; 🇨🇿 Hradec Králové, Czechia

CHRU Guy de Chauliac; 🇫🇷 Montpellier, France

Neurologische Praxis Dipl. med. Christian Oehlwein; 🇩🇪 Gera, Germany

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

Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

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

Pharmakologisches Studienzentrum Chemnitz; 🇩🇪 Mittweida, Germany

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály; 🇭🇺 Miskolc, Hungary

I. neurologická klinika Fakultní nemocnice u sv. Anny; 🇨🇿 Brno, Czechia

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States