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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
THN102 Dosage A
THN102 Dosage B
THN102 Dosage C
Sponsored by
Theranexus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kansas Medical Center
  • MGH Neurological Clinical Research Institute
  • Houston Methodist Hospital
  • I. neurologická klinika Fakultní nemocnice u sv. Anny
  • Neurologická klinika Fakultní nemocnice Hradec Králové
  • Neurologická klinika Fakultní nemocnice Ostrava
  • Institut neuropsychiatrické péče
  • Neurologická klinika 1.LF UK a VFN v Praze
  • NEURO - Praha, s.r.o.
  • Axon Clinical, s.r.o.
  • Neurologické oddělení Nemocnice Na Homolce
  • Hôpital NEurologique Pierre Wertheimer
  • CHRU Hopital Salengro
  • CHU de la Timone Service de Neuro et pathologie du mouvement
  • CHRU Guy de Chauliac
  • ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière
  • CHU Charles Nicolle
  • CHU Purpan CIC Hall D 2eme etage
  • Praxis Dr. Safavi, Neuroakademie Alzenau
  • Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin
  • Neurologische Praxis Dipl. med. Christian Oehlwein
  • Pharmakologisches Studienzentrum Chemnitz
  • Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum
  • Praxis Dr. med. Arnfin Bergmann
  • Neurozentrum Sophienstrasse
  • NeuroPoint
  • Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:
  • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály
  • Észak-Közép-budai Centrum
  • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály
  • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály
  • PTE KK Neurológiai Klinika
  • Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika
  • Theranexus Investigational site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

THN102 Dosage A

THN102 Dosage B

THN102 Dosage C

Arm Description

THN102 Dosage A is a Placebo

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 : 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

Outcomes

Primary Outcome Measures

Safety Adverse Events
Number of participants with spontaneously reported treatment-related adverse events

Secondary Outcome Measures

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.
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.
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.
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
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

Full Information

First Posted
July 10, 2018
Last Updated
November 27, 2020
Sponsor
Theranexus
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1. Study Identification

Unique Protocol Identification Number
NCT03624920
Brief Title
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Official Title
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 12, 2018 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
February 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Theranexus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Complete 3 way-Crossover
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
THN102 Dosage A
Arm Type
Placebo Comparator
Arm Description
THN102 Dosage A is a Placebo
Arm Title
THN102 Dosage B
Arm Type
Experimental
Arm Description
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
Arm Title
THN102 Dosage C
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
THN102 Dosage A
Other Intervention Name(s)
Placebo
Intervention Description
THN102 Dosages A: placebo
Intervention Type
Drug
Intervention Name(s)
THN102 Dosage B
Other Intervention Name(s)
Dosage B
Intervention Description
THN102 Dosage B : 200mg/2mg
Intervention Type
Drug
Intervention Name(s)
THN102 Dosage C
Other Intervention Name(s)
Dosage C
Intervention Description
THN102 Dosage C: 200mg/18mg
Primary Outcome Measure Information:
Title
Safety Adverse Events
Description
Number of participants with spontaneously reported treatment-related adverse events
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Epworth Sleeping Scale (ESS)
Description
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.
Time Frame
2 weeks
Title
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline
Description
PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.
Time Frame
2 weeks
Title
Montreal Cognitive Assessment Battery (MoCA)
Description
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.
Time Frame
2 weeks
Title
Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline
Description
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
Time Frame
2 weeks
Title
Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline
Description
Number of patients in remission (=without residual sleepiness), i.e. ESS < 11 at the end of each treatment period
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Corvol, Prof
Organizational Affiliation
Hôpital La Pitié-Salpêtrière, 75651 Paris, France, Tel. +33 1 42 16 57 66, mail: jean-christophe.corvol@aphp.fr
Official's Role
Study Chair
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
MGH Neurological Clinical Research Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
I. neurologická klinika Fakultní nemocnice u sv. Anny
City
Brno
ZIP/Postal Code
65691
Country
Czechia
Facility Name
Neurologická klinika Fakultní nemocnice Hradec Králové
City
Hradec Králové
ZIP/Postal Code
50005
Country
Czechia
Facility Name
Neurologická klinika Fakultní nemocnice Ostrava
City
Ostrava Poruba
ZIP/Postal Code
70852
Country
Czechia
Facility Name
Institut neuropsychiatrické péče
City
Praga 8
Country
Czechia
Facility Name
Neurologická klinika 1.LF UK a VFN v Praze
City
Praha 2
ZIP/Postal Code
12821
Country
Czechia
Facility Name
NEURO - Praha, s.r.o.
City
Praha 4
ZIP/Postal Code
14000
Country
Czechia
Facility Name
Axon Clinical, s.r.o.
City
Praha 5
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Neurologické oddělení Nemocnice Na Homolce
City
Praha 5
ZIP/Postal Code
15030
Country
Czechia
Facility Name
Hôpital NEurologique Pierre Wertheimer
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHRU Hopital Salengro
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de la Timone Service de Neuro et pathologie du mouvement
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
CHRU Guy de Chauliac
City
Montpellier
ZIP/Postal Code
34195
Country
France
Facility Name
ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Purpan CIC Hall D 2eme etage
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Praxis Dr. Safavi, Neuroakademie Alzenau
City
Alzenau In Unterfranken
ZIP/Postal Code
63755
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Neurologische Praxis Dipl. med. Christian Oehlwein
City
Gera
ZIP/Postal Code
05551
Country
Germany
Facility Name
Pharmakologisches Studienzentrum Chemnitz
City
Mittweida
ZIP/Postal Code
09648
Country
Germany
Facility Name
Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Praxis Dr. med. Arnfin Bergmann
City
Neuburg
ZIP/Postal Code
86633
Country
Germany
Facility Name
Neurozentrum Sophienstrasse
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
NeuroPoint
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Észak-Közép-budai Centrum
City
Budapest
Country
Hungary
Facility Name
Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály
City
Miskolc
ZIP/Postal Code
3526
Country
Hungary
Facility Name
PTE KK Neurológiai Klinika
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
Theranexus Investigational site
City
Szeged
Country
Hungary

12. IPD Sharing Statement

Plan to Share IPD
No

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

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