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

• Status: Completed
• Trial end date: 2020-02-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Theranexus

Criteria

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