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A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Primary Purpose

Idiopathic Hypersomnia

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Pitolisant Oral Tablet
Placebo oral tablet
Sponsored by
Harmony Biosciences, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypersomnia focused on measuring pitolisant, histamine, sleepiness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Is able to provide voluntary, written informed consent.
  2. Has a current diagnosis of IH per International Classification of Sleep Disorders Third Edition (ICSD 3) criteria.
  3. Male or female patient age ≥18 years at the time of Screening.
  4. Has an ESS score of ≥12 at Screening and at Baseline (Visit 2).
  5. Has a PGI-S score of moderate, severe, or very severe at Screening and at Baseline (Visit 2).
  6. For patients being treated for OSA or other hypoventilatory conditions, patients must be compliant as demonstrated by BiPAP/CPAP therapy with 30 days of data showing ≥4 hours of BiPAP/CPAP therapy per night for ≥70% of nights. If not on BiPAP/CPAP therapy, patients being treated for OSA must be compliant as determined by the Investigator with their medical device or oral appliance. Data must be from within 90 days prior to the Screening visit. Patients must agree to maintain compliance with their treatment for OSA throughout the duration of the study.
  7. If on a treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil):

    1. Must be on a stable dose for at least 2 months prior to Screening and agree to continue the stable dose for the duration of the study.
    2. If not on a stable dose for 2 months prior to Screening, washout for 5 half-lives or 14 days, whichever is longer, prior to Day 1 and agree to remain off these treatments until completion of the study.
  8. A patient who is a female of child-bearing potential (FCBP) must have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test at the Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4) and agree to remain abstinent or use an effective method of non-hormonal contraception to prevent pregnancy for the duration of the study and for 21 days after final dose of study drug.
  9. Must have a negative result on urine drug screen at the Screening Visit, Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4), except for medications that are prescribed by a healthcare provider for medical conditions.
  10. In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and administration of oral study drug.

Exclusion Criteria:

  1. Has hypersomnia due to another medical disorder (e.g., narcolepsy).
  2. Has an AHI of ≥10 as determined by the most recent sleep study or BiPAP/CPAP device readout.
  3. Has a clinically significant hypoventilatory condition as determined by the Investigator.
  4. Has a primary diagnosis of a psychiatric illness that is not well controlled.
  5. Patients taking antidepressants who have not been on a stable dose of their antidepressant for at least 12 weeks prior to Screening; patients on a stable dose of their antidepressant for at least 12 weeks prior to Screening must agree to continue their stable dose for the duration of the study.
  6. Experiences a mean of <6 hours of sleep per night based on sleep diary during Screening (patients need to record at least 7 nights within a 10-day period in their sleep diary within 14-days prior to the Baseline Visit [Visit 2]).
  7. Consistently consumes >600 mg of caffeine per day and is unable/unwilling to reduce caffeine intake to ≤600 mg per day for the duration of the study.
  8. Does not agree to discontinue any prohibited medication or substance listed in the protocol.
  9. Is currently or has previously used pitolisant.
  10. Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 21 days after final dose of study drug.
  11. Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 28 days or within 5 half-lives of the investigational medication (whichever is longer) prior to Screening.
  12. Has a diagnosis of ESRD (estimated glomerular filtration rate [eGFR] of <15 mL/minute/1.73 m²) or severe hepatic impairment (Child-Pugh C).
  13. Has a diagnosis of moderate or severe renal impairment (eGFR ≥15 to ≤59 mL/minute/1.73 m²) or moderate hepatic impairment (Child-Pugh B) at Screening or at any time during the study.
  14. Has a history of long corrected QT interval (QTc) syndrome or corrected QT interval using Fridericia's formula (QTcF) >450 msec for males or >470 msec for females (QTcF = QT / 3√ RR) at Screening.
  15. Is receiving and is unable to discontinue a medication known to prolong the QT interval.
  16. Is receiving a concomitant medication that is known to be a strong CYP3A4 inducer, or a centrally acting histamine 1 (H1) receptor antagonist; patients who undergo a washout of these medications of at least 5 half-lives or one week (whichever is longer) may be enrolled in the study. Use of strong CYP2D6 inhibitors is allowed; however, for these patients the maximum permitted daily dose of pitolisant is 17.8 mg.
  17. Is a known CYP2D6 poor metabolizer (PM).
  18. Has abnormal laboratory values at Screening that are clinically significant as determined by the Investigator.
  19. Has initiated any new or change in allied health therapies or interventions that can interfere with the study outcomes within 28 days prior to Screening and at any time during the study, based on the Investigator's judgment.
  20. Has a current or recent (within 1 year) history of a substance use disorder or dependence disorder, including alcohol, tobacco, and caffeine use disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
  21. Has planned surgery during the study.
  22. Has a significant risk of committing suicide or suicidality based on history; routine psychiatric examination; Investigator's judgment; or an answer of "yes" on any question other than questions 1 to 3 (for the previous month) or "yes" on any question in the suicidal behavior section (for the past year) of the Columbia-Suicide Severity Scale (C-SSRS), Baseline/Screening.
  23. Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to an unstable or uncontrolled medical condition or one that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the patient, or compromise the integrity of the study. This exclusion criterion applies not only to entry into the study, but also to continuation in the study, should such an unstable, uncontrolled, or serious medical condition arise.

Sites / Locations

  • Phoenix Medical Group
  • Mayo Clinic
  • Cedars-Sinai Medical Towers
  • University of California- Los Angeles
  • Sleep Medicine Specialists of California
  • SDS Clinical Trials Inc.
  • Santa Monica Clinical Trials
  • Alpine Clinical Research Center
  • Norwalk Hospital Sleep Center
  • Meris Clinical Research
  • St. Francis Medical Institute
  • Sleep Medicine Specialists of South Florida, PA
  • Pasadena Center For Medical Research, LLC
  • Florida Pediatric Research Institute
  • Neurotrials Research Inc.
  • The Neurological Center of North GA
  • Northwestern University
  • NorthShore Uni HealthSys-Glenbrook Hospital
  • OSF HealthCare Saint Francis Medical Center
  • Helene A. Emsellem MD PC
  • Boston Children's Hospital
  • Neurocare, INC
  • Henry Ford Health System
  • Bronson Sleep Health
  • Clinical Neurophysiology Services
  • Minnesota Lung Center
  • Minnesota Lung Center
  • St. Luke's Sleep Medicine and Research Center
  • Clayton Sleep Institute
  • Great Plains Health
  • Neurology Specialists of Monmouth County, PA
  • Northwell Health
  • Research Carolina Elite LLC
  • Duke University School of Medicine
  • Clinical Research of Gastonia
  • ARSM Research
  • NeuroScience Research Center, LLC
  • Intrepid Research, LLC
  • Rainbow Babies Children's Hospital
  • Cleveland Clinc
  • Ohio Sleep Medicine and Neuroscience Institue
  • North Star Medical Research
  • CardioVoyage
  • Brian Abaluck, LLC
  • Abington Neurological Associates
  • Respiratory Specialists
  • Medical University of South Carolina- Institute of Psychiatry
  • Bogan Sleep Consultants
  • Lowcountry Lung Critical Care
  • Advanced Center for Sleep Disorders
  • Neurology Clinic, P.C.
  • FutureSearch Trials of Neurology LP
  • Central Texas Neurology Consultants, PA
  • Comprehensive Sleep Medicine Associates
  • Northwest Houston Neurology and Sleep
  • Children's Hospital of the King's Daughter
  • West Virginia University - Department of Neurology
  • University of Wisconsin-Madison

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pitolisant

Matching Placebo

Arm Description

Dose Optimization Period: Week 1: 8.9 mg pitolisant administered once daily in the morning upon wakening; Week 2: 17.8 mg pitolisant administered once daily in the morning upon wakening; Weeks 3 through 6: 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening. Stable Dose Period: Weeks 7 through 8: Stable dose of 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening. Double-Blind Randomized Withdrawal Phase: Weeks 9 through 12: Stable dose of 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening.

Double-Blind Randomized Withdrawal Phase: Weeks 9 through 12: Matching placebo tablets.

Outcomes

Primary Outcome Measures

Excessive Daytime Sleepiness
Change in Epworth Sleepiness Scale score from the end of the Stable Dose Period to the end of the 4-week Double-Blind Randomized Withdrawal Phase for pitolisant compared with placebo. The score of the Epworth Sleepiness Scale ranges from 0 to 24. A decrease in score represents an improvement in excessive daytime sleepiness.

Secondary Outcome Measures

Symptoms of idiopathic hypersomnia
Change in Idiopathic Hypersomnia Severity Scale. The score of the Idiopathic Hypersomnia Severity Scale ranges from 0 to 50. A decrease in score represents an improvement in symptoms of idiopathic hypersomnia.
Symptoms of idiopathic hypersomnia
Percent of patients who worsen on the Patient Global Impression of Change. The Patient Global Impression of Change is a five item scale that ranges from much better to much worse. An assessment of being better represents an improvement in the patient's overall perception of the change in their idiopathic hypersomnia.
Symptoms of idiopathic hypersomnia
Change in Clinical Global Impression of Severity. The Clinical Global Impression of Severity is a five item scale that ranges from none to very severe. An assessment of less severe symptoms represents an improvement in the clinician's perception of the patient's overall clinical status related to idiopathic hypersomnia.
Symptoms of idiopathic hypersomnia
Change in Patient Global Impression of Severity of their excessive daytime sleepiness. The Patient Global Impression of Severity is a five item scale that ranges from none to very severe. An assessment of less severe symptoms represents an improvement in the patient's perception of the severity of their excessive daytime sleepiness.
Functional outcomes of sleep
Change in Functional Outcomes of Sleep Questionnaire 10-item Version. The score of the Functional Outcomes of Sleep Questionnaire 10-item Version ranges from 5 to 20. An increase in score represents an improvement in the patient's impression of the impact of hypersomnia on multiple activities of everyday living.
Sleep related impairments during wakefulness
Change in Patient-Reported Outcomes Measurement Information System, Sleep-Related Impairment. The score of the Patient-Reported Outcomes Measurement Information System, Sleep-Related Impairment ranges from 8 to 40. A decrease in score represents an improvement in the patient's impression of the impact of hypersomnia on multiple activities of everyday living.
Sleep inertia
Change in Sleep Inertia Questionnaire. The Sleep Inertia Questionnaire ranges from 21 to 105. A decrease in score represents an improvement in the patient's ability to wake up after sleep.
Working Memory
Change in Cogstate One Back Test. The Cogstate One Back Test is a computerized test. A faster speed represents a better working memory test performance.
Attention
Change in Cogstate Identification Test. The Cogstate Identification Test is a computerized test. A faster speed represents an improvement in attention test performance.
Psychomotor Function
Change in Cogstate Detection Test. The Cogstate Detection Test is a computerized test. A faster speed represents an improvement in psychomotor test performance.

Full Information

First Posted
December 1, 2021
Last Updated
August 30, 2023
Sponsor
Harmony Biosciences, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05156047
Brief Title
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
Official Title
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
August 9, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Harmony Biosciences, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in patients with idiopathic hypersomnia (IH) age ≥18 years. Key secondary objectives of this study are to assess the impact of pitolisant on: Overall symptoms of IH Patient impression of overall change in their symptoms of IH Investigator assessment of overall disease severity of IH Other secondary objectives of this study are to assess the impact of pitolisant in patients with IH on: Patient impression of overall severity of their EDS Functional status and activities of daily living Sleep-related impairment Sleep inertia Cognitive function
Detailed Description
This is a double-blind, placebo-controlled, randomized withdrawal study in adult patients (ages ≥18 years) with IH. The study will consist of a Screening Period (up to 28 days), an 8-week Open-Label Phase, and a 4-week Double-Blind Randomized Withdrawal Phase. The Open-Label Phase of the study will be 8 weeks, which includes a 6-week Dose Optimization Period and a 2-week Stable Dose Period. In the Dose Optimization Period, all patients will be titrated to their optimal dose of open-label pitolisant (17.8 mg or 35.6 mg) based on Investigator assessment of tolerability and efficacy. The 3-week titration period will be followed by 3 weeks of flexible dosing (weeks 4-6) during which patients will continue to receive their optimal dose of 17.8 mg or 35.6 mg open-label pitolisant. Patients taking a strong CYP2D6 inhibitor will be allowed in the study; however, for these patients, the maximum permitted daily dose of pitolisant will be 17.8 mg. Following completion of the 6-week Dose Optimization Period, patients will enter the 2-week Stable Dose Period. During this period, patients will remain at their optimal dose (the same dose they were taking at the end of the Dose Optimization Period [17.8 mg or 35.6 mg]) of open-label pitolisant for 2 weeks; dose adjustments are not allowed during the Stable Dose Period. At the end of the Stable Dose Period, patients will be defined as responders or non-responders. Responders will be randomized in a 1:1 ratio to receive blinded study drug (pitolisant or matching placebo) in the Double-Blind Randomized Withdrawal Phase of the study. Non-responders will not be randomized to treatment in the Double-Blind Randomized Withdrawal Phase and will complete two safety follow-up telephone contacts (TCs) at 15 (±3) days and 30 (+3) days after their final dose of open-label pitolisant. During the Double-Blind Randomized Withdrawal Phase, patients (approximately 64 patients per treatment group) will receive blinded study drug either at the same dose they were taking in the Stable Dose Period (17.8 mg or 35.6 mg pitolisant) or matching placebo. The duration of the Double-Blind Randomized Withdrawal Phase will be 4 weeks (weeks 9-12); dose adjustments are not permitted during this phase of the study. After completion of the Double-Blind Randomized Withdrawal Phase (End-of Treatment [EOT] Visit is on Day 84, the last day of blinded treatment), patients will complete two safety follow-up TCs with the site at 15 (±3) days and 30 (+3) days after their final dose of blinded study drug, which will include assessment for AEs and concomitant medication use; alternatively, patients will have the opportunity to enroll in a long-term, open-label safety study under a separate protocol. Patients who opt to enroll into the long-term, open-label study will not complete the 15 day and 30 day follow-up TCs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypersomnia
Keywords
pitolisant, histamine, sleepiness

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double-blind, randomized withdrawal
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pitolisant
Arm Type
Active Comparator
Arm Description
Dose Optimization Period: Week 1: 8.9 mg pitolisant administered once daily in the morning upon wakening; Week 2: 17.8 mg pitolisant administered once daily in the morning upon wakening; Weeks 3 through 6: 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening. Stable Dose Period: Weeks 7 through 8: Stable dose of 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening. Double-Blind Randomized Withdrawal Phase: Weeks 9 through 12: Stable dose of 17.8 or 35.6 mg pitolisant administered once daily in the morning upon wakening.
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
Double-Blind Randomized Withdrawal Phase: Weeks 9 through 12: Matching placebo tablets.
Intervention Type
Drug
Intervention Name(s)
Pitolisant Oral Tablet
Intervention Description
Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant. Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant.
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
Primary Outcome Measure Information:
Title
Excessive Daytime Sleepiness
Description
Change in Epworth Sleepiness Scale score from the end of the Stable Dose Period to the end of the 4-week Double-Blind Randomized Withdrawal Phase for pitolisant compared with placebo. The score of the Epworth Sleepiness Scale ranges from 0 to 24. A decrease in score represents an improvement in excessive daytime sleepiness.
Time Frame
Week 8 to Week 12
Secondary Outcome Measure Information:
Title
Symptoms of idiopathic hypersomnia
Description
Change in Idiopathic Hypersomnia Severity Scale. The score of the Idiopathic Hypersomnia Severity Scale ranges from 0 to 50. A decrease in score represents an improvement in symptoms of idiopathic hypersomnia.
Time Frame
Week 8 to Week 12
Title
Symptoms of idiopathic hypersomnia
Description
Percent of patients who worsen on the Patient Global Impression of Change. The Patient Global Impression of Change is a five item scale that ranges from much better to much worse. An assessment of being better represents an improvement in the patient's overall perception of the change in their idiopathic hypersomnia.
Time Frame
Week 8 to Week 12
Title
Symptoms of idiopathic hypersomnia
Description
Change in Clinical Global Impression of Severity. The Clinical Global Impression of Severity is a five item scale that ranges from none to very severe. An assessment of less severe symptoms represents an improvement in the clinician's perception of the patient's overall clinical status related to idiopathic hypersomnia.
Time Frame
Week 8 to Week 12
Title
Symptoms of idiopathic hypersomnia
Description
Change in Patient Global Impression of Severity of their excessive daytime sleepiness. The Patient Global Impression of Severity is a five item scale that ranges from none to very severe. An assessment of less severe symptoms represents an improvement in the patient's perception of the severity of their excessive daytime sleepiness.
Time Frame
Week 8 to Week 12
Title
Functional outcomes of sleep
Description
Change in Functional Outcomes of Sleep Questionnaire 10-item Version. The score of the Functional Outcomes of Sleep Questionnaire 10-item Version ranges from 5 to 20. An increase in score represents an improvement in the patient's impression of the impact of hypersomnia on multiple activities of everyday living.
Time Frame
Week 8 to Week 12
Title
Sleep related impairments during wakefulness
Description
Change in Patient-Reported Outcomes Measurement Information System, Sleep-Related Impairment. The score of the Patient-Reported Outcomes Measurement Information System, Sleep-Related Impairment ranges from 8 to 40. A decrease in score represents an improvement in the patient's impression of the impact of hypersomnia on multiple activities of everyday living.
Time Frame
Week 8 to Week 12
Title
Sleep inertia
Description
Change in Sleep Inertia Questionnaire. The Sleep Inertia Questionnaire ranges from 21 to 105. A decrease in score represents an improvement in the patient's ability to wake up after sleep.
Time Frame
Week 8 to Week 12
Title
Working Memory
Description
Change in Cogstate One Back Test. The Cogstate One Back Test is a computerized test. A faster speed represents a better working memory test performance.
Time Frame
Week 8 to Week 12
Title
Attention
Description
Change in Cogstate Identification Test. The Cogstate Identification Test is a computerized test. A faster speed represents an improvement in attention test performance.
Time Frame
Week 8 to Week 12
Title
Psychomotor Function
Description
Change in Cogstate Detection Test. The Cogstate Detection Test is a computerized test. A faster speed represents an improvement in psychomotor test performance.
Time Frame
Week 8 to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Is able to provide voluntary, written informed consent. Has a current diagnosis of IH per International Classification of Sleep Disorders Third Edition (ICSD 3) criteria. Male or female patient age ≥18 years at the time of Screening. Has an ESS score of ≥12 at Screening and at Baseline (Visit 2). Has a PGI-S score of moderate, severe, or very severe at Screening and at Baseline (Visit 2). For patients being treated for OSA or other hypoventilatory conditions, patients must be compliant as demonstrated by BiPAP/CPAP therapy with 30 days of data showing ≥4 hours of BiPAP/CPAP therapy per night for ≥70% of nights. If not on BiPAP/CPAP therapy, patients being treated for OSA must be compliant as determined by the Investigator with their medical device or oral appliance. Data must be from within 90 days prior to the Screening visit. Patients must agree to maintain compliance with their treatment for OSA throughout the duration of the study. If on a treatment that could affect daytime sleepiness (including but not limited to oxybates, stimulants, modafinil, and armodafinil): Must be on a stable dose for at least 2 months prior to Screening and agree to continue the stable dose for the duration of the study. If not on a stable dose for 2 months prior to Screening, washout for 5 half-lives or 14 days, whichever is longer, prior to Day 1 and agree to remain off these treatments until completion of the study. A patient who is a female of child-bearing potential (FCBP) must have a negative serum pregnancy test at the Screening Visit and negative urine pregnancy test at the Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4) and agree to remain abstinent or use an effective method of non-hormonal contraception to prevent pregnancy for the duration of the study and for 21 days after final dose of study drug. Must have a negative result on urine drug screen at the Screening Visit, Baseline Visit (Visit 2) and at the end of the Stable Dose Period (Visit 4), except for medications that are prescribed by a healthcare provider for medical conditions. In the opinion of the Investigator, the patient is capable of understanding and complying with the protocol and administration of oral study drug. Exclusion Criteria: Has hypersomnia due to another medical disorder (e.g., narcolepsy). Has an AHI of ≥10 as determined by the most recent sleep study or BiPAP/CPAP device readout. Has a clinically significant hypoventilatory condition as determined by the Investigator. Has a primary diagnosis of a psychiatric illness that is not well controlled. Patients taking antidepressants who have not been on a stable dose of their antidepressant for at least 12 weeks prior to Screening; patients on a stable dose of their antidepressant for at least 12 weeks prior to Screening must agree to continue their stable dose for the duration of the study. Experiences a mean of <6 hours of sleep per night based on sleep diary during Screening (patients need to record at least 7 nights within a 10-day period in their sleep diary within 14-days prior to the Baseline Visit [Visit 2]). Consistently consumes >600 mg of caffeine per day and is unable/unwilling to reduce caffeine intake to ≤600 mg per day for the duration of the study. Does not agree to discontinue any prohibited medication or substance listed in the protocol. Is currently or has previously used pitolisant. Is currently breastfeeding or planning to breastfeed over the course of the study. Lactating women must agree not to breastfeed for the duration of the study and for 21 days after final dose of study drug. Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 28 days or within 5 half-lives of the investigational medication (whichever is longer) prior to Screening. Has a diagnosis of ESRD (estimated glomerular filtration rate [eGFR] of <15 mL/minute/1.73 m²) or severe hepatic impairment (Child-Pugh C). Has a diagnosis of moderate or severe renal impairment (eGFR ≥15 to ≤59 mL/minute/1.73 m²) or moderate hepatic impairment (Child-Pugh B) at Screening or at any time during the study. Has a history of long corrected QT interval (QTc) syndrome or corrected QT interval using Fridericia's formula (QTcF) >450 msec for males or >470 msec for females (QTcF = QT / 3√ RR) at Screening. Is receiving and is unable to discontinue a medication known to prolong the QT interval. Is receiving a concomitant medication that is known to be a strong CYP3A4 inducer, or a centrally acting histamine 1 (H1) receptor antagonist; patients who undergo a washout of these medications of at least 5 half-lives or one week (whichever is longer) may be enrolled in the study. Use of strong CYP2D6 inhibitors is allowed; however, for these patients the maximum permitted daily dose of pitolisant is 17.8 mg. Is a known CYP2D6 poor metabolizer (PM). Has abnormal laboratory values at Screening that are clinically significant as determined by the Investigator. Has initiated any new or change in allied health therapies or interventions that can interfere with the study outcomes within 28 days prior to Screening and at any time during the study, based on the Investigator's judgment. Has a current or recent (within 1 year) history of a substance use disorder or dependence disorder, including alcohol, tobacco, and caffeine use disorders as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Has planned surgery during the study. Has a significant risk of committing suicide or suicidality based on history; routine psychiatric examination; Investigator's judgment; or an answer of "yes" on any question other than questions 1 to 3 (for the previous month) or "yes" on any question in the suicidal behavior section (for the past year) of the Columbia-Suicide Severity Scale (C-SSRS), Baseline/Screening. Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to an unstable or uncontrolled medical condition or one that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the patient, or compromise the integrity of the study. This exclusion criterion applies not only to entry into the study, but also to continuation in the study, should such an unstable, uncontrolled, or serious medical condition arise.
Facility Information:
Facility Name
Phoenix Medical Group
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Mayo Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Cedars-Sinai Medical Towers
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
University of California- Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Sleep Medicine Specialists of California
City
San Ramon
State/Province
California
ZIP/Postal Code
94583
Country
United States
Facility Name
SDS Clinical Trials Inc.
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Santa Monica Clinical Trials
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Norwalk Hospital Sleep Center
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06850
Country
United States
Facility Name
Meris Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
St. Francis Medical Institute
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Sleep Medicine Specialists of South Florida, PA
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Pasadena Center For Medical Research, LLC
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33763
Country
United States
Facility Name
Florida Pediatric Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Neurotrials Research Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
The Neurological Center of North GA
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
NorthShore Uni HealthSys-Glenbrook Hospital
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
OSF HealthCare Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Helene A. Emsellem MD PC
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Neurocare, INC
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02459
Country
United States
Facility Name
Henry Ford Health System
City
Novi
State/Province
Michigan
ZIP/Postal Code
48377
Country
United States
Facility Name
Bronson Sleep Health
City
Portage
State/Province
Michigan
ZIP/Postal Code
49024
Country
United States
Facility Name
Clinical Neurophysiology Services
City
Sterling Heights
State/Province
Michigan
ZIP/Postal Code
48314
Country
United States
Facility Name
Minnesota Lung Center
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Minnesota Lung Center
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
St. Luke's Sleep Medicine and Research Center
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63123
Country
United States
Facility Name
Great Plains Health
City
North Platte
State/Province
Nebraska
ZIP/Postal Code
69101
Country
United States
Facility Name
Neurology Specialists of Monmouth County, PA
City
West Long Branch
State/Province
New Jersey
ZIP/Postal Code
07764
Country
United States
Facility Name
Northwell Health
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Research Carolina Elite LLC
City
Denver
State/Province
North Carolina
ZIP/Postal Code
28037
Country
United States
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
ARSM Research
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
NeuroScience Research Center, LLC
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Intrepid Research, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Rainbow Babies Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio Sleep Medicine and Neuroscience Institue
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43017
Country
United States
Facility Name
North Star Medical Research
City
Middleburg
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
CardioVoyage
City
Ardmore
State/Province
Oklahoma
ZIP/Postal Code
73401
Country
United States
Facility Name
Brian Abaluck, LLC
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301
Country
United States
Facility Name
Abington Neurological Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Respiratory Specialists
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Medical University of South Carolina- Institute of Psychiatry
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Bogan Sleep Consultants
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Lowcountry Lung Critical Care
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Advanced Center for Sleep Disorders
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Neurology Clinic, P.C.
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
FutureSearch Trials of Neurology LP
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Central Texas Neurology Consultants, PA
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Comprehensive Sleep Medicine Associates
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Northwest Houston Neurology and Sleep
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
Children's Hospital of the King's Daughter
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
West Virginia University - Department of Neurology
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
University of Wisconsin-Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53719
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

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