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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03624920
Other study ID # THN102-202
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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