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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.

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.
Read More
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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
THN102 Dosage ATHN102 Dosage ATHN102 Dosage A is a Placebo
THN102 Dosage BTHN102 Dosage BTHN102 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 CTHN102 Dosage CTHN102 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
NameTimeMethod
Safety Adverse Events2 weeks

Number of participants with spontaneously reported treatment-related adverse events

Secondary Outcome Measures
NameTimeMethod
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline2 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 Baseline2 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 Baseline2 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

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