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

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

  • Parkinson Disease

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.