FAQs

Why consider the ONSTRIDE-2 study?

Study volunteers are an essential part of this important idiopathic hypersomnia management research. Your participation and experience in the ONSTRIDE-2 study may possibly help scientists and researchers gain helpful insights about the investigational drug. Your participation in a clinical study is voluntary. You may decide not to participate or you may leave the study at any time.

Why is the ONSTRIDE-2 study important?

People with idiopathic hypersomnia may still experience persistent symptoms or unwanted side effects while taking available medicines. Scientists and researchers are actively exploring idiopathic hypersomnia by developing and testing investigational drugs through clinical research studies. The ONSTRIDE-2 study is being conducted to learn more about an investigational drug called HBS-301 (pitolisant delayed-release HD tablets) for adults with idiopathic hypersomnia.

What is the purpose of the ONSTRIDE-2 study?

In this study, researchers will evaluate the safety and efficacy of an investigational oral drug (HBS-301) in adults with idiopathic hypersomnia.

How long will this study last?

Participation in this study is expected to last approximately 16 weeks. After the final study visit, you may have the opportunity to participate in an open-label extension period where all participants will receive HBS-301 for approximately 1 year. The study staff will provide more information about this optional extension period.

What can I expect if I decide to participate?

The ONSTRIDE-2 study consists of the following:

Screening/Baseline Period (Up to 28 days)

• To determine if you meet the requirements to enroll in this study.

Study treatment period (8 weeks)

• All eligible participants will be randomly assigned (by chance) to receive the study drug (HBS-301) or placebo oral tablets during this period. You will also attend weekly telehealth (telephone and/or video teleconference) visits and two onsite clinic visits so your health and safety can be monitored.

Open-label extension period
(optional; about 1 year)

• All eligible participants will have the option to continue in the study and begin taking HBS-301 during this period. You will also attend monthly telehealth visits and 3 onsite clinic visits.

Follow-up period
(about 30 days after the final dose of study drug)

• You will have 2 follow-up telehealth visits approximately 15 days and 30 days after the last dose of study drug or placebo. All participants will enter the Follow-Up Period regardless of enrollment in the Open-Label Extension Period.

What are my costs to take part in this study?

The study drug or placebo will be given at no cost to you, and you will not be charged for any study-related visits, tests, or procedures. Assistance with study-related expenses may be available to eligible participants.

What about my private health information?

The study doctor and staff will handle all personal health information in a confidential manner. Personal health information includes both a participant’s study data and original medical records. To protect your privacy, your name and other personal information will not be identified unless necessary for study purposes. Instead, you will be identified only by a code.