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ClinicalTrials.gov public records Last synced Sep 5, 2026, 6:06 PM EDT

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Showing 1–15 of 15 matching trials from the live ClinicalTrials.gov search.
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Conditions
Narcolepsy
Interventions
HBS-201
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025
U.S. locations
15
States / cities
San Ramon, California • Brandon, Florida • Miami, Florida + 12 more
Conditions
Restless Legs Syndrome
Interventions
Pitolisant
Drug
Lead sponsor
William Ondo, MD
Other
Eligibility
21 Years to 80 Years
Enrollment
18 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
1
States / cities
Houston, Texas
Conditions
Myotonic Dystrophy 1, Excessive Daytime Sleepiness
Interventions
Pitolisant Oral Tablet, Placebo oral tablet
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years to 65 Years
Enrollment
30 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
11
States / cities
Irvine, California • Aurora, Colorado • Tampa, Florida + 8 more
Conditions
Idiopathic Hypersomnia, Excessive Daytime Sleepiness
Interventions
Pitolisant
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years and older
Enrollment
119 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
32
States / cities
Los Angeles, California • San Ramon, California • Brandon, Florida + 29 more
Recruiting No phase listed Observational

WAKIX® (Pitolisant) Pregnancy Registry

NCT05536011
Conditions
Pregnancy Related, Narcolepsy
Interventions
Pitolisant, Comparator Products
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
Female only
Enrollment
1,329 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
1
States / cities
Morrisville, North Carolina
Conditions
Prader-Willi Syndrome
Interventions
Pitolisant tablet, Placebo tablet
Drug · Other
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
6 Years and older
Enrollment
134 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
23
States / cities
Los Angeles, California • Sacramento, California • San Diego, California + 16 more
Conditions
Idiopathic Hypersomnia
Interventions
HBS-301 tablet, Placebo
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years and older
Enrollment
248 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2028
U.S. locations
40
States / cities
Birmingham, Alabama • Peoria, Arizona • Redwood City, California + 36 more
Conditions
Alcohol Use Disorder, Alcohol Drinking
Interventions
Pitolisant, Placebo
Drug
Lead sponsor
Boston Medical Center
Other
Eligibility
21 Years to 55 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2023
U.S. locations
1
States / cities
Boston, Massachusetts
Conditions
Narcolepsy Without Cataplexy, Narcolepsy With Cataplexy
Interventions
Pitolisant
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years and older
U.S. locations
71
States / cities
Birmingham, Alabama • Cullman, Alabama • Phoenix, Arizona + 60 more
Conditions
Type 1 Diabetes, Hypoglycemia
Interventions
Pitolisant
Drug
Lead sponsor
High Point Clinical Trials Center
Industry
Eligibility
18 Years to 65 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
1
States / cities
High Point, North Carolina
Conditions
Schizophrenia
Interventions
BF2.649, Placebo
Drug
Lead sponsor
University of Texas Southwestern Medical Center
Other
Eligibility
18 Years to 55 Years
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008 – 2011
U.S. locations
2
States / cities
Dallas, Texas
Conditions
Prader-Willi Syndrome
Interventions
Pitolisant oral tablets, Placebo oral tablet
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
6 Years to 65 Years
Enrollment
65 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2026
U.S. locations
13
States / cities
San Diego, California • San Ramon, California • Santa Monica, California + 10 more
Conditions
Prader-Willi Syndrome
Interventions
Pitolisant
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
7 Years and older
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2030
U.S. locations
1
States / cities
Morrisville, North Carolina
Conditions
EDS, Cataplexy, Fatigue, Narcolepsy
Interventions
HBS-301, Placebo
Drug · Other
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years and older
Enrollment
258 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
51
States / cities
Birmingham, Alabama • Mobile, Alabama • Peoria, Arizona + 46 more
Conditions
Idiopathic Hypersomnia
Interventions
Open-label pitolisant, Double-blind placebo, Double-blind pitolisant
Drug
Lead sponsor
Harmony Biosciences Management, Inc.
Industry
Eligibility
18 Years and older
Enrollment
214 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2023
U.S. locations
58
States / cities
Peoria, Arizona • Scottsdale, Arizona • Los Angeles, California + 53 more