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?

This trial examines the tolerance of a new treatment called HBS-201 for narcolepsy, a condition characterized by extreme daytime sleepiness and sudden sleep episodes. Participants will take this medication once daily for two weeks to assess any side effects at a therapeutic dose. Individuals diagnosed with either type 1 or type 2 narcolepsy, who are not taking certain other narcolepsy medications, might be suitable for this study. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking WAKIX (pitolisant). It's best to discuss your medications with the study team.

Is there any evidence suggesting that HBS-201 is likely to be safe for humans?

Research has shown that HBS-201 is based on pitolisant, a drug the FDA has approved for treating excessive daytime sleepiness in adults with narcolepsy. This approval indicates that pitolisant is generally safe for that condition. Although specific safety data for HBS-201 is not yet available, the current trial primarily assesses how well participants can tolerate it at a treatment dose.

As a Phase 1 trial, it is in the early stages of human testing. The main objectives are to determine the appropriate dose and identify any side effects. While risks may exist, pitolisant's prior approval provides some confidence in its overall safety. Participants should discuss any concerns with the trial team to understand what to expect. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for narcolepsy?

Unlike the standard treatments for narcolepsy, which often include stimulants like modafinil or sodium oxybate, HBS-201 is unique because it is taken orally once daily in the morning and is designed to potentially offer more convenient dosing. Researchers are excited about HBS-201 because it has a novel mechanism of action that may provide more consistent wakefulness throughout the day compared to current options. Additionally, the potential for HBS-201 to show effectiveness within just 14 days makes it a promising candidate for those seeking quicker relief from narcolepsy symptoms.

What evidence suggests that HBS-201 might be an effective treatment for narcolepsy?

Research has shown that pitolisant, the main ingredient in HBS-201, helps treat narcolepsy symptoms. Studies have found that it reduces excessive daytime sleepiness and sudden muscle weakness (cataplexy) in patients. One study demonstrated significant improvement in symptoms for patients taking pitolisant. This treatment increases histamine levels in the brain, promoting wakefulness and alertness. These promising results suggest that HBS-201, which participants in this trial will take, could effectively manage narcolepsy symptoms. ^{1 2 3 6 7}

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+

Citations

1. ctv.veeva.com ctv.veeva.com/study/a-study-of-hbs-201-pitolisant-delayed-release

A Study of HBS-201 (Pitolisant Delayed-release) The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.

2. withpower.com withpower.com/clinical-trials/for-narcolepsy

Top Narcolepsy Clinical Trials | Power The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy. No Placebo Group.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07051252

A Study of HBS-201 (Pitolisant Delayed-release) There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

4. trial.medpath.com trial.medpath.com/clinical-trial/c0881df9cc7dfed7/nct07051252-hbs-201-pitolisant-adult-narcolepsy

A Study of HBS-201 (Pitolisant Delayed-release) - MedPath The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33721598/

Efficacy of pitolisant in patients with high burden ... Conclusions: Pitolisant, at once-daily doses up to 35.6 mg, was efficacious for reducing excessive daytime sleepiness and cataplexy in patients with severe ...

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2021/211150Orig2s000MedR.pdf

211150Orig2s000 CLINICAL REVIEW(S) - accessdata.fda.gov Pitolisant received FDA approval for the treatment of EDS in adult patients with narcolepsy in August 2019 (NDA 211150, trade name Wakix).

7. synapse.patsnap.com synapse.patsnap.com/drug/d67935ae97e745519d9300f4fa4293e1

Pitolisant Hydrochloride - Drug Targets, Indications, Patents The safety and effectiveness of WAKIX have not been established for treatment of cataplexy in pediatric patients with narcolepsy. WAKIX is extensively ...