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Completed Phase 1 Interventional

A Study of HBS-201 (Pitolisant Delayed-release)

ClinicalTrials.gov ID: NCT07051252

Public ClinicalTrials.gov record NCT07051252. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 5:33 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07051252
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Enrollment
46 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 21, 2025 (Actual)
Primary completion
Oct 13, 2025 (Actual)
Completion
Oct 13, 2025 (Actual)
Last update posted
Dec 12, 2025

2025

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
15
Facility City State ZIP Site status
Harmony Site 9 San Ramon California 94583 —
Harmony Site 14 Brandon Florida 33511 —
Harmony Site 4 Miami Florida 33176 —
Harmony Site 8 Atlanta Georgia 30328 —
Harmony Site 13 Newton Massachusetts 02459 —
Harmony Site 11 Troy Michigan 48085 —
Harmony Site 10 Denver North Carolina 28037 —
Harmony Site 2 Huntersville North Carolina 28078 —
Harmony Site 6 Canton Ohio 44718 —
Harmony Site 1 Cincinnati Ohio 45245 —
Harmony Site 15 Wyomissing Pennsylvania 19610 —
Harmony Site 5 Columbia South Carolina 29201 —
Harmony Site 12 North Charleston South Carolina 29406 —
Harmony Site 3 Austin Texas 78731 —
Harmony Site 7 Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07051252, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 12, 2025 · Synced Oct 20, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07051252 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →