Jazz Pharmaceuticals has enrolled the first patient in a Phase 2 clinical trial evaluating its drug candidate JZP-110 as a potential treatment for excessive sleepiness in patients with Parkinson’s disease.
JZP-110 is a selective dopamine and norepinephrine reuptake inhibitor (DNRI) in late-stage development for the treatment of excessive sleepiness in adults with narcolepsy or obstructive sleep apnea (OSA).
Dopamine and norepinephrine are neurotransmitters involved in the sleep cycle regulation, and are used in medications that target both excessive sleep and insomnia. By targeting its uptake by cells, JZP-110 promotes the increase of extracellular levels of both neurotransmitters, which tips the balance for the awake state.
The Phase 2 trial (NCT03037203) is recruiting participants at about 15 centers in the U.S. according to a press release. For more information about enrolling, click on the clinical trial number above.
The trial is a double-blind, placebo-controlled, randomized, crossover study that will evaluate the safety, effectiveness and pharmacokinetics of JZP-110 in about 50 adults with Parkinson’s and excessive sleepiness.
The trial’s primary outcome measure is to assess safety by the incidence of treatment emergent adverse events up until the last visit, at week five.
Secondary outcome measures include assessing the effect of JZP-110 on the Maintenance of Wakefulness Test (MWT) compared to baseline vs. placebo for four weeks; and assessing the effect of JZP-110 on the Epworth Sleepiness Scale (ESS) score compared to baseline vs. placebo, also for four weeks. The study is estimated to be completed in April 2018.
Excessive sleepiness is a common nonmotor symptom of Parkinson’s disease, affecting 20 to 50 percent of patients. It significantly increases the disease burden of Parkinson’s and is a big cause of reported reduced quality of life in patients. Excessive sleepiness is also a concern for the safety of patients, as it may lead to an increased risk of falls and motor vehicle accidents.
“We are interested in determining whether the wake-promoting effects of JZP-110 could be beneficial in this patient population,” Karen Smith, MD, PhD, Jazz Pharmaceuticals’ global head of research and development and chief medical officer, said in a press release.
“The initiation of this study is another step forward in our development program for JZP-110 and our efforts to develop new treatment options for people with sleep disorders,” she said.
The U.S. Food and Drug Administration (FDA) has not yet approved JZP-110 or any other drugs for the treatment of excessive sleepiness in Parkinson’s disease patients. The FDA has granted Orphan Drug status to JZP-110 for the treatment of narcolepsy, according to Jazz Pharmaceuticals.