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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624920
• Other study ID #: THN102-202
• Status: Completed
• Phase: Phase 2
• Start date: July 12, 2018
• Est. completion date: February 24, 2020

Study information

• Verified date: October 2020
• Source: Theranexus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 24, 2020
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Sleepiness

Intervention

Drug:
• THN102 Dosage A
THN102 Dosages A: placebo
• THN102 Dosage B
THN102 Dosage B : 200mg/2mg
• THN102 Dosage C
THN102 Dosage C: 200mg/18mg

Locations

Country	Name	City	State
Czechia	I. neurologická klinika Fakultní nemocnice u sv. Anny	Brno
Czechia	Neurologická klinika Fakultní nemocnice Hradec Králové	Hradec Králové
Czechia	Neurologická klinika Fakultní nemocnice Ostrava	Ostrava Poruba
Czechia	Institut neuropsychiatrické péce	Praga 8
Czechia	Neurologická klinika 1.LF UK a VFN v Praze	Praha 2
Czechia	NEURO - Praha, s.r.o.	Praha 4
Czechia	Axon Clinical, s.r.o.	Praha 5
Czechia	Neurologické oddelení Nemocnice Na Homolce	Praha 5
France	Hôpital NEurologique Pierre Wertheimer	Bron
France	CHRU Hopital Salengro	Lille
France	CHU de la Timone Service de Neuro et pathologie du mouvement	Marseille
France	CHRU Guy de Chauliac	Montpellier
France	ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière	Paris
France	CHU Charles Nicolle	Rouen
France	CHU Purpan CIC Hall D 2eme etage	Toulouse
Germany	Praxis Dr. Safavi, Neuroakademie Alzenau	Alzenau In Unterfranken
Germany	Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin	Berlin
Germany	Neurologische Praxis Dipl. med. Christian Oehlwein	Gera
Germany	Pharmakologisches Studienzentrum Chemnitz	Mittweida
Germany	Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum	München
Germany	Praxis Dr. med. Arnfin Bergmann	Neuburg
Germany	Neurozentrum Sophienstrasse	Stuttgart
Germany	NeuroPoint	Ulm
Germany	Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:	Westerstede
Hungary	Észak-Közép-budai Centrum	Budapest
Hungary	Nyíro Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály	Budapest
Hungary	Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály	Debrecen
Hungary	Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály	Miskolc
Hungary	PTE KK Neurológiai Klinika	Pécs
Hungary	Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika	Szeged
Hungary	Theranexus Investigational site	Szeged
United States	MGH Neurological Clinical Research Institute	Boston	Massachusetts
United States	Houston Methodist Hospital	Houston	Texas
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Theranexus

Countries where clinical trial is conducted

United States,  Czechia,  France,  Germany,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Adverse Events	Number of participants with spontaneously reported treatment-related adverse events	2 weeks
Secondary	Epworth Sleeping Scale (ESS)	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.	2 weeks
Secondary	Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline	PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.	2 weeks
Secondary	Montreal Cognitive Assessment Battery (MoCA)	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.	2 weeks
Secondary	Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline	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	2 weeks
Secondary	Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline	Number of patients in remission (=without residual sleepiness), i.e. ESS < 11 at the end of each treatment period	2 weeks