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Parkinson DiseasePhase 2NCT03624920

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

A Phase 2 study testing THN102 Dosage A, THN102 Dosage B and THN102 Dosage C in people with Parkinson Disease, run by Theranexus at 34 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Parkinson Disease
What is being tested?
THN102 Dosage A, THN102 Dosage B and THN102 Dosage C
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
77 participants
Where
34 sitesin 5 countries
Study dates
12 Jul 2018to 24 Feb 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

34 sites in 5 countries.

34 sites in 5 countries

Germany9 sites

  • Praxis Dr. Safavi, Neuroakademie Alzenau

    Alzenau in Unterfranken, 63755

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

    Berlin, 12203

  • Neurologische Praxis Dipl. med. Christian Oehlwein

    Gera, 05551

  • Pharmakologisches Studienzentrum Chemnitz

    Mittweida, 09648

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

    München, 81675

  • Praxis Dr. med. Arnfin Bergmann

    Neuburg am Inn, 86633

  • Neurozentrum Sophienstrasse

    Stuttgart, 70178

  • NeuroPoint

    Ulm, 89073

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

    Westerstede, 26655

Other trials in Germany

Czechia8 sites

  • I. neurologická klinika Fakultní nemocnice u sv. Anny

    Brno, 65691

  • Neurologická klinika Fakultní nemocnice Hradec Králové

    Hradec Králové, 50005

  • Neurologická klinika Fakultní nemocnice Ostrava

    Ostrava Poruba, 70852

  • Neurologická klinika 1.LF UK a VFN v Praze

    Prague, 12821

  • NEURO - Praha, s.r.o.

    Prague, 14000

  • Axon Clinical, s.r.o.

    Prague, 15030

  • Neurologické oddělení Nemocnice Na Homolce

    Prague, 15030

  • Institut neuropsychiatrické péče

    Prague

Other trials in Czechia

France7 sites

  • Hôpital NEurologique Pierre Wertheimer

    Bron, 69677

  • CHRU Hopital Salengro

    Lille, 59037

  • CHU de la Timone Service de Neuro et pathologie du mouvement

    Marseille, 13385

  • CHRU Guy de Chauliac

    Montpellier, 34195

  • ICM Centre d'Investigation Clinique Hôpital Pitié Salpêtrière

    Paris, 75013

  • CHU Charles Nicolle

    Rouen, 76031

  • CHU Purpan CIC Hall D 2eme etage

    Toulouse, 31059

Other trials in France

Hungary7 sites

  • Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet, Neurológiai Osztály

    Budapest, 1135

  • Észak-Közép-budai Centrum

    Budapest

  • Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Neurológiai Osztály

    Debrecen, 4031

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

    Miskolc, 3526

  • PTE KK Neurológiai Klinika

    Pécs, 7623

  • Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ Neurológiai Klinika

    Szeged, 6725

  • Theranexus Investigational site

    Szeged

Other trials in Hungary

United States3 sites

  • MGH Neurological Clinical Research Institute

    Boston, Massachusetts, 02114

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

Other trials in United States

About this study

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.

Read the detailed description

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

Being tested
THN102 Dosage A, THN102 Dosage B, THN102 Dosage C
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • THN102 Dosage ADrug

    Also called Placebo

    THN102 Dosages A: placebo

  • THN102 Dosage BDrug

    Also called Dosage B

    THN102 Dosage B : 200mg/2mg

  • THN102 Dosage CDrug

    Also called Dosage C

    THN102 Dosage C: 200mg/18mg

Study groups in NCT03624920
Study groupRoleWhat they receive
THN102 Dosage APlacebo comparatorTHN102 Dosage A is a Placebo
Receives: Drug: THN102 Dosage A
THN102 Dosage BExperimentalTHN102 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
Receives: Drug: THN102 Dosage B
THN102 Dosage CExperimentalTHN102 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
Receives: Drug: THN102 Dosage C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Adverse Events

    Number of participants with spontaneously reported treatment-related adverse events

    Measured: 2 weeks

Secondary outcomes (5)

  1. 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.

    Measured: 2 weeks

  2. 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.

    Measured: 2 weeks

  3. 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.

    Measured: 2 weeks

  4. 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

    Measured: 2 weeks

  5. 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

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2018
  2. Study start12 Jul 2018
  3. Primary completion20 Dec 2019
  4. Study completion24 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Complete 3 way-Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03624920
Sponsor's protocol ID
THN102-202
Status last verified
Oct 2020
First submitted
10 Jul 2018
Last updated
1 Dec 2020
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing THN102 Dosage A, THN102 Dosage B and THN102 Dosage C in people with Parkinson Disease, run by Theranexus at 34 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Germany, Czechia, France, Hungary, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Adverse Events (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03624920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2020.

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