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Tests treatment safety and results for EDS
Official title A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy
ClinicalTrials.gov ID: NCT07675135
What this study is testing
What is HBS-301?
HBS-301 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for eds.
Also referred to as pitolisant delayed-release.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in treating excessive daytime sleepiness (EDS), cataplexy, sleepiness/wakefulness, and fatigue in adult participants (ages ≥18 years) with narcolepsy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text...
- Has EDS.
- If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a...
You likely can't join if
- Has hypersomnia due to another medical disorder.
- Has a history of pitolisant use within 5 half-lives prior to Screening.
- Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been...
- Has any history of bipolar disorder or psychosis
- Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
- Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
See the full eligibility criteria
- Has a current documented diagnosis of NT1 or NT2 per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or the ICSD-3 Text Revision (ICSD-3-TR) within the last 10 years.
- Has EDS.
- If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to...
- Has hypersomnia due to another medical disorder.
- Has a history of pitolisant use within 5 half-lives prior to Screening.
- Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled (i.e., symptoms and medications have not been stable for at least 3 months prior to Screening).
- Has any history of bipolar disorder or psychosis
- Has acute or chronic liver disease or a history of moderate or severe hepatic impairment.
- Has a body surface area-corrected estimated glomerular filtration rate (eGFR) \<60 mL/min.
- Has a known history of long QT syndrome or serious abnormality of the electrocardiogram (ECG).
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Arizona, United States
- Los Angeles, California, United States
- Boulder, Colorado, United States
- Miami, Florida, United States
- Winter Park, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Cincinnati, Ohio, United States
- Wyomissing, Pennsylvania, United States
- Charleston, South Carolina, United States
- Columbia, South Carolina, United States
- Dallas, Texas, United States
- San Antonio, Texas, United States
- Spokane, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Arizona, United States; Los Angeles, California, United States; Boulder, Colorado, United States; Miami, Florida, United States; Winter Park, Florida, United States; Atlanta, Georgia, United States and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.