Pitolisant

Generic Name: Pitolisant

Brand Names: Wakix, Ozawade

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₂₆ClNO

CAS Number: 362665-56-3

Unique Ingredient Identifier: 4BC83L4PIY

Background: Pitolisant is a selective antagonist or inverse agonist of the histamine H3 receptor used to treat type 1 or 2 narcolepsy. Narcolepsy is a chronic neurological disorder that affects 1 in 2,000 individuals and is characterized by excessive daytime sleepiness, abnormal REM sleep manifestations, sleep paralysis and hypnagogic hallucinations. About 60-70% of pat...

Indication: Pitolisant is indicated for the treatment of narcolepsy with or without cataplexy and excessive daytime sleepiness in narcolepsy in adult patients.

Associated Conditions: Excessive Daytime Sleepiness, Narcolepsy With Cataplexy, Narcolepsy Without Cataplexy

Associated Therapies: -

Clinical Trials

Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and Adolescents

Phase 2

Not yet recruiting

Conditions: Autism Spectrum Disorder

Interventions: Drug: Placebo
Drug: Pitolisant

First Posted Date: 2023-07-20

Last Posted Date: 2023-07-20

Lead Sponsor: Bioprojet

Target Recruit Count: 62

Registration Number: NCT05953389

Locations: 🇫🇷
Centre Hospitalier Charles Perrens, Bordeaux, France
🇫🇷
Nantes University Hospital, Nantes, France
🇫🇷
CH le Rouvray, Sotteville-lès-Rouen, France

and more 12 locations

Pitolisant in Refractory Restless Legs Syndrome

Phase 4

Recruiting

Conditions: Restless Legs Syndrome

Interventions: Drug: Pitolisant

First Posted Date: 2022-10-14

Last Posted Date: 2022-10-14

Lead Sponsor: William Ondo, MD

Target Recruit Count: 18

Registration Number: NCT05581576

Locations: 🇺🇸
Houston Methodist Hospital, Houston, Texas, United States

WAKIX® (Pitolisant) Pregnancy Registry

Recruiting

Conditions: Pregnancy Related
Narcolepsy

Interventions: Drug: Comparator Products
Drug: Pitolisant

First Posted Date: 2022-09-10

Last Posted Date: 2024-01-25

Lead Sponsor: Harmony Biosciences, LLC

Target Recruit Count: 1329

Registration Number: NCT05536011

Locations: 🇺🇸
Evidera (PPD), Morrisville, North Carolina, United States

A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Phase 3

Active, not recruiting

Conditions: Idiopathic Hypersomnia
Excessive Daytime Sleepiness

Interventions: Drug: Pitolisant

First Posted Date: 2022-07-14

Last Posted Date: 2024-01-25

Lead Sponsor: Harmony Biosciences, LLC

Target Recruit Count: 128

Registration Number: NCT05458128

Locations: 🇺🇸
Clinical Neurophysiology Services, Sterling Heights, Michigan, United States
🇺🇸
Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, Michigan, United States
🇺🇸
Sleep Dynamics, Neptune City, New Jersey, United States

and more 29 locations

A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSA

Phase 3

Completed

Conditions: Excessive Daytime Sleepiness

Interventions: Drug: Pitolisant
Drug: Placebo oral tablet

First Posted Date: 2022-02-03

Last Posted Date: 2023-07-20

Lead Sponsor: Citrine Medicine Limited

Target Recruit Count: 240

Registration Number: NCT05223166

Locations: 🇨🇳
Tsinghua Changgung Hospital, Beijing, China

Pitolisant Effects on Alcohol Self-Administration in Heavy Drinkers

Phase 1

Terminated

Conditions: Alcohol Drinking
Alcohol Use Disorder

Interventions: Drug: Placebo
Drug: Pitolisant

First Posted Date: 2020-10-22

Last Posted Date: 2023-12-04

Lead Sponsor: Boston Medical Center

Target Recruit Count: 9

Registration Number: NCT04596267

Locations: 🇺🇸
Boston University Psychiatry Research Center, Clinical Studies Unit, Boston, Massachusetts, United States

Insulin Tolerance Test Study in Patients With Type 1 Diabetes

Phase 1

Terminated

Conditions: Hypoglycemia
Type 1 Diabetes

Interventions: Drug: Pitolisant

First Posted Date: 2019-07-19

Last Posted Date: 2021-04-02

Lead Sponsor: High Point Clinical Trials Center

Target Recruit Count: 5

Registration Number: NCT04026750

Locations: 🇺🇸
High Point Clinical Trials Center, High Point, North Carolina, United States

Expanded Access Program to Provide Treatment With Pitolisant to Adult Patients in the U.S. With Excessive Daytime Sleepiness Associated With Narcolepsy With or Without Cataplexy

Conditions: Narcolepsy Without Cataplexy
Narcolepsy With Cataplexy

First Posted Date: 2018-02-14

Last Posted Date: 2019-08-28

Lead Sponsor: Harmony Biosciences, LLC

Registration Number: NCT03433131

Locations: 🇺🇸
St. Lukes Hospital, Sleep Medicine, Chesterfield, Missouri, United States
🇺🇸
Emory University, Atlanta, Georgia, United States
🇺🇸
Northwestern Medical Group, Chicago, Illinois, United States

and more 64 locations

Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant Users

Phase 1

Completed

Conditions: Healthy
Drug Abuse

Interventions: Drug: Placebos
Drug: Phentermine
Drug: Pitolisant

First Posted Date: 2017-05-12

Last Posted Date: 2017-11-13

Lead Sponsor: Bioprojet

Target Recruit Count: 43

Registration Number: NCT03152123

Locations: 🇨🇦
INC Research, Toronto, Ontario, Canada

Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male Volunteers

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Radiation: [14C]-Pitolisant
Drug: Pitolisant

First Posted Date: 2016-10-11

Last Posted Date: 2016-10-11

Lead Sponsor: Bioprojet

Target Recruit Count: 8

Registration Number: NCT02929342

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