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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Complete 3 way-Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Completed
Sponsor
Theranexus

Study Contact

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.