HBS-201 for Narcolepsy
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Open-Label Treatment
Participants receive HBS-201 orally once daily in the morning for 2 weeks
Safety Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Harmony Biosciences Management, Inc.
Lead Sponsor
Citations
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.
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.
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-narcolepsyA 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.
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 ...
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).
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 ...
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