Idiopathic Hypersomnia Trials
XYRISE Trial
PARTICIPATE IN THE XYRISE RESEARCH STUDY
Are you living with narcolepsy or idiopathic hypersomnia (IH)? You may be eligible to participate in a clinical research study evaluating expanded dosing options for Xywav.
This Phase 3 clinical research study is evaluating the effectiveness and safety of expanded Xywav dosing regimens in adults with narcolepsy or idiopathic hypersomnia.
Xywav is an FDA-approved medication. This study is investigating expanded dosing approaches, including once-nightly and twice-nightly dosing regimens.
WHO MAY QUALIFY?
You may be eligible if you:
Are between 18 and 75 years of age
Have a diagnosis of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH)
Meet additional medication and symptom requirements, depending on your current or previous oxybate treatment
Medication-related screening considerations may include:
If you are not currently taking an oxybate medication, you must have clinically significant daytime sleepiness, generally reflected by an Epworth Sleepiness Scale (ESS) score greater than 11 at screening.
If you currently take an oxybate medication, your symptoms must have improved with treatment, and you must have been taking a stable total nightly dose of 3–9 grams for at least 2 months.
If you previously took an oxybate medication but are no longer taking it, you must have been off treatment for at least 2 weeks and must not have stopped because of intolerance, safety concerns, or lack of effectiveness.
Participants with NT1 must meet additional cataplexy-related requirements.
Other inclusion and exclusion criteria apply. A study physician will determine final eligibility.
WHAT DOES PARTICIPATION INVOLVE?
Participation includes three treatment periods and may involve up to approximately 16 weeks of study treatment, following screening and confirmation of eligibility.
1. Dose Titration and Optimization
Participants receive open-label Xywav.
Dosing is adjusted to identify a stable, appropriate regimen.
Participants are assigned to a once-nightly or twice-nightly dosing approach.
2. Stable Dose Period
Participants continue their established Xywav dose for an additional 2 weeks.
3. Double-Blind Randomized-Withdrawal Period
Participants are randomly assigned to either continue their stable Xywav dose or receive placebo for 2 weeks.
Neither participants nor the study team know the assigned treatment during this period.
Study visits, assessments, and safety monitoring will occur throughout participation.
WHAT IS THE STUDY EVALUATING?
Researchers are evaluating the effectiveness and safety of expanded Xywav dosing regimens, including:
Daytime sleepiness and related symptoms
The ability to maintain symptom control
Safety and tolerability of the study dosing regimens
Outcomes in participants with narcolepsy and idiopathic hypersomnia
IMPORTANT INFORMATION
Participation is voluntary. There is no guarantee of direct medical benefit. During the randomized-withdrawal period, participants may receive placebo instead of active study medication.
As with any medication, Xywav has potential risks and side effects. These will be reviewed with you by the study team before you decide whether to participate.
Contact the research team to discuss the study and whether you may qualify.
Interested? Email us at research@tricoastalsleep.com or click here.
ONSTRIDE-2 Trial
PARTICIPATE IN THE ONSTRIDE-2 RESEARCH STUDY
Are you living with idiopathic hypersomnia (IH)? You may be eligible to participate in a clinical research study evaluating a new formulation and dosing approach for pitolisant.
This Phase 3 clinical research study is evaluating the effectiveness and safety of HBS-301 in adults with idiopathic hypersomnia. Researchers are studying its effects on excessive daytime sleepiness, IH symptoms, sleep inertia, and fatigue.
WHO MAY QUALIFY?
You may be eligible if you:
Are 18 years of age or older
Have a documented diagnosis of idiopathic hypersomnia
Have excessive daytime sleepiness
Have moderate to very severe IH symptoms
Have diagnostic sleep testing supporting your IH diagnosis
Diagnostic documentation considerations:
A prior polysomnogram (PSG) and multiple sleep latency test (MSLT) supporting the IH diagnosis must be available.
When applicable, a 24-hour PSG report or actigraphy report with sleep log may also be required.
Diagnostic testing must generally have been completed within the past 10 years.
Medication-related considerations:
Certain wake-promoting medications and antidepressants may be permitted if taken at a stable dose for at least 3 months before screening.
Participants must be willing to maintain permitted medications at a stable dose during the blinded treatment period.
As-needed use of medications that may affect daytime sleepiness, including stimulants, modafinil, and armodafinil, is not permitted.
Recent pitolisant use may affect eligibility.
Additional inclusion and exclusion criteria apply. A study physician will determine final eligibility.
WHAT DOES PARTICIPATION INVOLVE?
The study includes:
1. Screening and Baseline
Up to 28 days
Review of medical history and current medications
Confirmation of IH diagnosis and prior sleep testing
Assessment of daytime sleepiness and IH symptoms
Safety assessments
2. Double-Blind Treatment
8 weeks
Participants are randomly assigned to receive HBS-301 or placebo.
Neither participants nor the study team know which treatment is assigned.
Study visits and assessments monitor symptoms and safety.
3. Optional Open-Label Extension
Eligible participants may have the opportunity to receive open-label HBS-301 for up to 1 year.
4. Safety Follow-Up
30 days of safety follow-up after treatment.
WHAT IS THE STUDY EVALUATING?
Researchers are evaluating:
Excessive daytime sleepiness
Overall severity of IH symptoms
Sleep inertia and difficulty waking
Fatigue
Safety and tolerability of HBS-301
IMPORTANT INFORMATION
Participation is voluntary. Participants may receive HBS-301 or placebo during the 8-week treatment period. There is no guarantee of direct medical benefit.
Potential risks and side effects will be discussed with you by the study team before participation.
Contact the research team to discuss the study and whether you may qualify.