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

November 27, 2020 updated by: Theranexus
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Brno, Czechia, 65691
        • I. neurologická klinika Fakultní nemocnice u sv. Anny
      • Hradec Králové, Czechia, 50005
        • Neurologická klinika Fakultní nemocnice Hradec Králové
      • Ostrava Poruba, Czechia, 70852
        • Neurologická klinika Fakultní nemocnice Ostrava
      • Praga 8, Czechia
        • Institut neuropsychiatricke pece
      • Praha 2, Czechia, 12821
        • Neurologická klinika 1.LF UK a VFN v Praze
      • Praha 4, Czechia, 14000
        • NEURO - Praha, s.r.o.
      • Praha 5, Czechia, 15030
        • Axon Clinical, s.r.o.
      • Praha 5, Czechia, 15030
        • Neurologické oddělení Nemocnice Na Homolce
  • France
      • Bron, France, 69677
        • Hôpital Neurologique Pierre Wertheimer
      • Lille, France, 59037
        • CHRU Hopital Salengro
      • Marseille, France, 13385
        • CHU de la Timone Service de Neuro et pathologie du mouvement
      • Montpellier, France, 34195
        • CHRU Guy de Chauliac
      • Paris, France, 75013
        • ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière
      • Rouen, France, 76031
        • CHU Charles Nicolle
      • Toulouse, France, 31059
        • CHU Purpan CIC Hall D 2eme etage
  • Germany
      • Alzenau In Unterfranken, Germany, 63755
        • Praxis Dr. Safavi, Neuroakademie Alzenau
      • Berlin, Germany, 12203
        • Charité - Universitätsmedizin Berlin, Klinik für Neurologie, Campus Benjamin Franklin
      • Gera, Germany, 05551
        • Neurologische Praxis Dipl. med. Christian Oehlwein
      • Mittweida, Germany, 09648
        • Pharmakologisches Studienzentrum Chemnitz
      • München, Germany, 81675
        • Technische Universität München, Klinikum rechts der Isar, Neurologische Klinik und Poliklinik, Neuro-Kopf-Zentrum
      • Neuburg, Germany, 86633
        • Praxis Dr. med. Arnfin Bergmann
      • Stuttgart, Germany, 70178
        • Neurozentrum Sophienstraße
      • Ulm, Germany, 89073
        • NeuroPoint
      • Westerstede, Germany, 26655
        • Gemeinschaftspraxis Dr. med. Joachim Springub / Wolfgang Schwarz, Studienzentrum Nord-West, *ausgelagerte Praxisräume:
  • Hungary
      • Budapest, Hungary, 1135
        • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály
      • Budapest, Hungary
        • Észak-Közép-budai Centrum
      • Debrecen, Hungary, 4031
        • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály
      • Miskolc, Hungary, 3526
        • Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Oktató Kórház, Stroke, Vascularis és Általános Neurológiai és Toxikológiai Osztály
      • Pécs, Hungary, 7623
        • PTE KK Neurológiai Klinika
      • Szeged, Hungary, 6725
        • Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika
      • Szeged, Hungary
        • Theranexus Investigational site
  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Neurological Clinical Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: THN102 Dosage A
THN102 Dosage A is a Placebo
Drug: THN102 Dosage A
THN102 Dosages A: placebo
Other Names:
  • Placebo
Experimental: THN102 Dosage B
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 B : 200mg/2mg
Other Names:
  • Dosage B
Experimental: THN102 Dosage C
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
THN102 Dosage C: 200mg/18mg
Other Names:
  • Dosage C

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Adverse Events
Time Frame: 2 weeks
Number of participants with spontaneously reported treatment-related adverse events
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth Sleeping Scale (ESS)
Time Frame: 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.
2 weeks
Psychomotor Vigilance Test (PVT) : Reaction Time (Miliseconds) Change From Baseline
Time Frame: 2 weeks
PVT measures reaction time in milliseconds. The results below are corresponding to the reaction time change from baseline.
2 weeks
Montreal Cognitive Assessment Battery (MoCA)
Time Frame: 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.
2 weeks
Efficacy in Improving Sleepiness (ESS). Responders Rate, Change From Baseline
Time Frame: 2 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
2 weeks
Efficacy in Improving Sleepiness (ESS). Patients in Remission, Change From Baseline
Time Frame: 2 weeks
Number of patients in remission (=without residual sleepiness), i.e. ESS < 11 at the end of each treatment period
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Theranexus

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 10, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 1, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • THN102-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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