FAQs
Why consider the ONSTRIDE-2 study?
Study volunteers are an essential part of this idiopathic hypersomnia 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 studying 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 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 adult idiopathic hypersomnia.
How long will this study last?
Participation in this study is expected to last approximately 16 weeks. After completing the 8-week Study Treatment Period, 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.
How do I know if I’m eligible for this study?
Splash Clinical is a clinical study recruitment and patient support partner working with the ONSTRIDE-2 study team. Splash Clinical helps you learn if you are eligible for the study by completing a brief questionnaire. After you submit the questionnaire, a Splash Clinical team member will reach out to answer questions and, based on your questionnaire responses and possible eligibility, help coordinate next steps (e.g., introduction to the site study team at the closest clinic site or at the virtual site). The investigator at the study site will confirm final eligibility requirements and determine whether you are able to join the study.
What can I expect if I decide to participate?
The ONSTRIDE-2 study consists of:
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 (by chance) assigned 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 three onsite clinic visits so your health and safety can be monitored.
Open-label extension period
(optional; about 1 year)
- At the end of the Study Treatment Period, eligible participants will have the option to continue in the study and begin taking HBS-301 during this period. You will also have monthly telehealth visits and 4 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.
- Dose adjustments will be made for participants taking specific medications.
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.