Ireland-based biopharmaceutical company Jazz Pharmaceuticals has begun enrolment in its Phase II clinical trial of JZP-110 to treat excessive sleepiness (ES) in adult patients with Parkinson's disease.
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) designed to treat adult patients with narcolepsy or obstructive sleep apnea (OSA).
Expected to enrol up to 50 patients, the double-blind, placebo-controlled, randomised, multicentre, cross-over trial will evaluate the safety, efficacy and pharmacokinetics of the drug.
Jazz Pharmaceuticals research and development global head Karen Smith said: "Excessive sleepiness is a debilitating symptom of Parkinson's disease, and we are interested in determining whether the wake-promoting effects of JZP-110 could be beneficial in this patient population.
"The initiation of this study is another step forward in our development programme for JZP-110 and our efforts to develop new treatment options for people with sleep disorders."
Parkinson's disease is a chronic neurodegenerative brain disorder with motor and non-motor symptoms such as ES, which may result in an enhanced risk for falls and motor vehicle accidents.
The JZP-110 is being studied in a Phase III clinical trial programme, which includes two studies evaluating ES in adult patients with OSA, one study evaluating ES in adult patients with narcolepsy and an open-label long-term safety study.
While the enrolment has been closed in the OSA and narcolepsy studies, the open-label study is currently enrolling subjects.
With the orphan drug designation in the US for narcolepsy, Jazz Pharmaceuticals holds the development, manufacturing, and commercialisation rights to JZP-110, except in certain Asian jurisdictions.