The path forward for idiopathic hypersomnia starts with new research.
The ONSTRIDE-2 study is enrolling adults 18 and older with idiopathic hypersomnia (IH) to evaluate an investigational drug for IH symptoms — excessive daytime sleepiness, sleep inertia, and fatigue. Conducted locally by the research team at Sleep and Attention Disorders Institute.
- No-cost study drug and study-related visits
- Weekly telehealth check-ins with the study team
- Assistance with study-related expenses may be available
Understanding idiopathic hypersomnia
Sleeping enough, but never feeling rested?
Idiopathic hypersomnia (IH) is a chronic neurological sleep disorder. “Idiopathic” means the cause is unknown — but the exhaustion is very real, and it can affect work, relationships, and daily life.
If this sounds familiar and you’ve been diagnosed with IH, a clinical research study may be an option to explore.
See If You May QualifyAbout the study
What is the ONSTRIDE-2 study?
ONSTRIDE-2 is a clinical research study evaluating the safety and efficacy of an investigational drug called HBS-301 (pitolisant delayed-release tablets) for adults with excessive daytime sleepiness and idiopathic hypersomnia.
People with idiopathic hypersomnia may still experience persistent symptoms or unwanted side effects while taking available medicines. Scientists and researchers are actively studying IH by developing and testing investigational drugs through clinical research studies like ONSTRIDE-2.
The study is sponsored by Harmony Biosciences and conducted locally by the research team at Sleep and Attention Disorders Institute, where you’ll be cared for by physicians who specialize in sleep disorders.
Check Your Eligibility- Expected participation
- ~16 weeks
- Study treatment period
- 8 weeks
- Optional open-label extension
- 1 year
- Telehealth visits during treatment
- Weekly
New to clinical research?
Why participate
What participation offers
Study volunteers are an essential part of this important research. Your participation is voluntary — you may decide not to participate, or leave the study at any time.
Access to clinical research
Play an active role in the future of idiopathic hypersomnia care by taking part in ongoing IH research.
No-cost study drug
The study drug or placebo is provided at no cost to you throughout the study.
No-cost study visits
You will not be charged for any study-related visits, tests, or procedures.
Close medical monitoring
Your health and safety are monitored closely by the study team, including weekly telehealth check-ins during treatment.
Help with study expenses
Assistance with study-related expenses may be available to eligible participants.
Optional 1-year extension
Eligible participants may join an optional open-label extension period, during which all participants receive HBS-301.
Who may qualify
You may qualify for ONSTRIDE-2 if you are:
18 years of age or older
The study is enrolling adults only.
Diagnosed with idiopathic hypersomnia
A confirmed IH diagnosis from a healthcare provider.
Living with IH symptoms
Such as excessive daytime sleepiness, sleep inertia, or fatigue.
This is not a complete list of study requirements. The study doctor will review all of the requirements with you — the quickest way to find out is the two-minute eligibility check below.
Take the 2-Minute Eligibility CheckWhat participation looks like
Your journey through the study
Participation is expected to last approximately 16 weeks, unless you choose to enter the optional open-label extension period.
- 1Up to 28 days
Screening / Baseline
Tests and assessments will be done to determine if you meet the requirements to enroll in this study.
- 28 weeks
Study Treatment
You'll be randomly assigned to take HBS-301 or placebo tablets once daily in the morning. This is a double-blind study — neither you nor the study team will know which you're receiving. Weekly telehealth visits monitor your health and safety.
- 3About 30 days
Follow-Up
Two follow-up telehealth visits, approximately 15 and 30 days after the last dose of study drug or placebo.
- 4About 1 year · optional
Open-Label Extension
If you're eligible and decide to join after the treatment period, you'll begin taking HBS-301 — all extension participants receive the study drug — with monthly telehealth visits and 4 onsite clinic visits.
Laboratory and heart tests, physical examinations, questionnaires, and other assessments may be done at some visits. Dose adjustments will be made for participants taking specific medications.
Meet our research team
Real people, right here in your community
The ONSTRIDE-2 study is conducted locally at Sleep and Attention Disorders Institute — you'll know the team caring for you by name.
Principal Investigator
[Principal Investigator Name], MD
Board-certified sleep medicine physician leading the ONSTRIDE-2 study at our site, with [X] years of experience caring for people with sleep disorders.
Sub-Investigator
[Sub-Investigator Name], MD
Physician specializing in sleep and attention disorders, supporting participant care and safety monitoring throughout the study.
Clinical Research Coordinator
[Study Coordinator Name]
Your main point of contact — guiding you through screening, scheduling, and every question along the way.
2-minute eligibility check
Am I eligible for the ONSTRIDE-2 study?
Answer the following questions to check if you may be eligible for the ONSTRIDE-2 study. This is not a complete list of requirements — the study doctor will review all of the requirements with you.
Frequently asked questions
Answers before you decide
Still have questions? Our research team is happy to talk them through.
Contact Our Research TeamContact us
Talk with our research team
Prefer to speak with a person first? Call, email, or visit — we'll answer your questions with no obligation to participate.
- (555) 000-0000
- research@sleepattentioninstitute.com
- [Street Address], [City], [State] [ZIP]
- Monday – Friday, 8:00 AM – 5:00 PM
