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

Theranexus

Status and phase: Completed; Phase 2

Conditions: Parkinson Disease

Treatments: Drug: THN102 Dosage B; Drug: THN102 Dosage A; Drug: THN102 Dosage C

Study type: Interventional

Funder types: Industry

Identifiers

NCT03624920

THN102-202

Details and patient eligibility

About

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.

Full description

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

Enrollment: 77 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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77 participants in 3 patient groups, including a placebo group

THN102 Dosage A

Placebo Comparator group

Description:

THN102 Dosage A is a Placebo

Treatment:

Drug: THN102 Dosage A

THN102 Dosage B

Experimental group

Description:

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

Treatment:

Drug: THN102 Dosage B

THN102 Dosage C

Experimental group

Description:

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

Treatment:

Drug: THN102 Dosage C