What is the PASSAGE Study?

The PASSAGE Study is a clinical research study looking at the safety and efficacy of an investigational medication for sleepiness in patients with Parkinson's disease (PD).  A clinical research study is a medical study designed to answer salient questions about a potential new medication such as whether it improves a patient's health or causes any side effects.

The PASSAGE Study will:

• look at an investigational medication that comes as a capsule taken with or without food, once a day with water in the morning, after waking up
• look at how the investigational medication affects your level of sleepiness, how it works in your body, and how safe it is
• last for about 9 weeks and involve 7 visits to the study center
• enroll a total of 49 people in 15 study sites in the United States
• look at whether the investigational medication reduces sleepiness in patients with PD by comparing the response with a placebo (which looks like a medication but contains no active ingredients)
• test which dose of the investigational medication works best to reduce sleepiness
• let you continue taking your regular PD and certain sleep medications during the study
• place you into 1 of 3 groups using a computer that assigns you by chance, like drawing names from a hat.  Most people (42 of 49) in the study will receive the investigational medication.  The rest of the people (7 of 49) will receive the placebo only.  Both you and the study doctor will not know which medication you are receiving.

Who Can Take Part in the PASSAGE Study?

You can take part in the study if you:

• are between 35 and 80 years of age (inclusive)
• have a diagnosis of PD
• experience excessive daytime sleepiness, despite spending 6 or more hours in bed
• have not been diagnosed with obstructive sleep apnea or narcolepsy

How do I find out more?

To learn more about the PASSAGE study, please contact the study team today at 1-877-630-5934

We look forward to hearing from you!!