HBS-201 for Narcolepsy

Recruiting at 14 trial locations

Overseen By Michelle Manuel

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Harmony Biosciences Management, Inc.

Must not be taking: WAKIX

Disqualifiers: Hypersomnolence, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.

Are You a Good Fit for This Trial?

This clinical trial is for adults with narcolepsy. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of narcolepsy.

Inclusion Criteria

I have been diagnosed with narcolepsy type 1 or 2.

Exclusion Criteria

Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening

Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.

I have excessive sleepiness caused by another health condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Open-Label Treatment

Participants receive HBS-201 orally once daily in the morning for 2 weeks

2 weeks

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HBS-201

Trial Overview The study is testing the tolerability of HBS-201 (Pitolisant Delayed-release), which is likely a medication designed to manage symptoms of narcolepsy. The focus is on how patients handle starting at a therapeutic dose.

How Is the Trial Designed?

Group I: HBS-201 Experimental Treatment 1 Intervention

Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.

Who Is Running the Clinical Trial?

Harmony Biosciences Management, Inc.

Lead Sponsor

Trials

9

Recruited

2,000+