Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.
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.
5. Has a PGI-S score of moderate, severe, or very severe at Screening.
6. For patients with a diagnosis of 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 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.
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) except for managed
OSA.
2. Has known unmanaged OSA or has an AHI of ≥10 with or without BiPAP/CPAP or other
therapeutic management.
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.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/1/22. Questions regarding updates should be directed to the study team contact.