Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Avadel
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Primary diagnosis of idiopathic hypersomnia
Total ESS score at Screening \> 11 if not on prior oxybate
Average nightly total sleep time of \> 7 hours
May use stimulants/alerting agents but dose and regimen must have been stable for 2 months prior to Screening, and remain stable until the double-blind, randomized withdrawal visit
Females of childbearing potential must use highly effective contraception for 2 months prior to Baseline, throughout the study, and for 30 days after the last dose of study drug
Males with female partners of childbearing potential must use condoms throughout the study and for 30 days after the last dose of study drug
Willing and able to provide informed consent and comply with the requirements of the study
You may not be if
Pregnant, nursing or lactating females
Hypersomnia due to another medical, behavioral, sleep, or psychiatric condition
Untreated or incompletely treated sleep apnea in patients with an apnea-hypopnea index (AHI) ≥ 15 by American Academy of Sleep Medicine (AASM) 1A criteria
Clinically significant parasomnias
History or presence of seizures, head trauma, succinic semialdehyde dehydrogenase deficiency, uncontrolled hypothyroidism, and/or significant hepatic impairment
History or presence of bipolar and related disorders, schizophrenia, schizophrenia spectrum disorders, or other psychotic disorders
Ongoing or past (within 1 year) major depressive episode
At risk for suicide or history of suicide attempt
If not on oxybate at Screening, treatment or planned treatment with any central nervous system (CNS) sedating agents during study
Current or past substance use disorder (including alcohol or cannabinoids)
