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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2 parkinson-disease

Timeline

Completed

Started Jul 2018

Geographic Reach

5 countries

34 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

July 10, 2018

Completed

2 days until next milestone

Study Start

First participant enrolled

July 12, 2018

Completed

29 days until next milestone

First Posted

Study publicly available on registry

August 10, 2018

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2020

Completed

9 months until next milestone

Results Posted

Study results publicly available

December 1, 2020

Completed

Last Updated

December 1, 2020

Status Verified

October 1, 2020

Enrollment Period

1.4 years

First QC Date

July 10, 2018

Results QC Date

September 27, 2020

Last Update Submit

November 27, 2020

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

Epworth Sleeping Scale (ESS)
2 weeks
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline
2 weeks
Montreal Cognitive Assessment Battery (MoCA)
2 weeks
Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline
2 weeks
Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline
2 weeks

Study Arms (3)

THN102 Dosage A

PLACEBO COMPARATOR

THN102 Dosage A is a Placebo

Drug: THN102 Dosage A

THN102 Dosage B

EXPERIMENTAL

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

Drug: THN102 Dosage B

THN102 Dosage C

EXPERIMENTAL

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

Drug: THN102 Dosage C

Interventions

THN102 Dosage ADRUG

THN102 Dosages A: placebo

Also known as: Placebo

THN102 Dosage A

THN102 Dosage BDRUG

THN102 Dosage B : 200mg/2mg

Also known as: Dosage B

THN102 Dosage B

THN102 Dosage CDRUG

THN102 Dosage C: 200mg/18mg

Also known as: Dosage C

THN102 Dosage C

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Theranexuslead

Study Sites (34)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MGH Neurological Clinical Research Institute

Boston, Massachusetts, 02114, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

I. neurologická klinika Fakultní nemocnice u sv. Anny

Brno, 65691, Czechia

Location

Neurologická klinika Fakultní nemocnice Hradec Králové

Hradec Králové, 50005, Czechia

Location

Neurologická klinika Fakultní nemocnice Ostrava

Ostrava Poruba, 70852, Czechia

Location

Neurologická klinika 1.LF UK a VFN v Praze

Prague, 12821, Czechia

Location

NEURO - Praha, s.r.o.

Prague, 14000, Czechia

Location

Axon Clinical, s.r.o.

Prague, 15030, Czechia

Location

Neurologické oddělení Nemocnice Na Homolce

Prague, 15030, Czechia

Location

Institut neuropsychiatrické péče

Prague, Czechia

Location

Hôpital NEurologique Pierre Wertheimer

Bron, 69677, France

Location

CHRU Hopital Salengro

Lille, 59037, France

Location

CHU de la Timone Service de Neuro et pathologie du mouvement

Marseille, 13385, France

Location

CHRU Guy de Chauliac

Montpellier, 34195, France

Location

ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

CHU Charles Nicolle

Rouen, 76031, France

Location

CHU Purpan CIC Hall D 2eme etage

Toulouse, 31059, France

Location

Praxis Dr. Safavi, Neuroakademie Alzenau

Alzenau in Unterfranken, 63755, Germany

Location

Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin

Berlin, 12203, Germany

Location

Neurologische Praxis Dipl. med. Christian Oehlwein

Gera, 05551, Germany

Location

Pharmakologisches Studienzentrum Chemnitz

Mittweida, 09648, Germany

Location

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

München, 81675, Germany

Location

Praxis Dr. med. Arnfin Bergmann

Neuburg am Inn, 86633, Germany

Location

Neurozentrum Sophienstrasse

Stuttgart, 70178, Germany

Location

NeuroPoint

Ulm, 89073, Germany

Location

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

Westerstede, 26655, Germany

Location

Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály

Budapest, 1135, Hungary

Location

Észak-Közép-budai Centrum

Budapest, Hungary

Location

Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály

Debrecen, 4031, Hungary

Location

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály

Miskolc, 3526, Hungary

Location

PTE KK Neurológiai Klinika

Pécs, 7623, Hungary

Location

Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika

Szeged, 6725, Hungary

Location

Theranexus Investigational site

Szeged, Hungary

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title: Chief Medical Officer
Organization: Theranexus

Study Officials

Jean-Christophe Corvol, Prof
Hôpital La Pitié-Salpêtrière, 75651 Paris, France, Tel. +33 1 42 16 57 66, mail: jean-christophe.corvol@aphp.fr
STUDY CHAIR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: CROSSOVER
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 10, 2018

First Posted

August 10, 2018

Study Start

July 12, 2018

Primary Completion

December 20, 2019

Study Completion

February 24, 2020

Last Updated

December 1, 2020

Results First Posted

December 1, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing: Will not share

Locations

US(3)FR(7)HU(7)CZ(8)DE(9)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

THN102 Dosage A

THN102 Dosage B

THN102 Dosage C

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (34)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations