Study of SDX in Patients With Idiopathic Hypersomnia (IH)

Completed · Phase 2 · Has a placebo group

Conditions studied: Idiopathic Hypersomnia

In brief

This is a study of the safety, efficacy and pharmacokinetics (PK) of Serdexmethylphenidate (SDX) compared to placebo in subjects with Idiopathic Hypersomnia (IH).

Key facts

Study ID

NCT05668754

Run by

Zevra Therapeutics

People needed

66

Starts

2022-12-28

Expected to finish

2024-03-21

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age at the time of consent
• Body Mass Index (BMI) ≤35 kg/m2
• Documented primary diagnosis of IH according to the International Classification of Sleep Disorders (ICSD-3) criteria
• At the Screening Visit and Baseline Visit (start of OLTP), Epworth Sleepiness Scale (ESS) scores ≥11
• Average nightly Total Sleep Time (TST) of ≥7 hours, per subject history and confirmed during screening.
• Subject must be in general good health defined as the absence of any clinically relevant abnormalities as determined by the Investigator based on physical and neurological examinations, vital signs, ECGs, medical history, and clinical laboratory values (hematology, chemistry, and urinalysis) at Screening.
• If currently treated with nicotine replacement therapy, must have been taking the same regimen and dose for at least 2 months prior to screening and must agree to take the same dose during the study.
• Have used a medically acceptable method of contraception for at least 2 months prior to the first dose of study drug and consent to use a medically acceptable method of contraception from the first dose of study drug, throughout the entire study period, and for 90 days after the last dose of study drug.

You may not qualify if…

• Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (eg, narcolepsy, depression disorders, multiple sclerosis, Parkinson's disease, stroke).
• Clinically significant sleep-related breathing disorders, including sleep apnea, treatment with Continuous Positive Airway Pressure (CPAP) therapy, Obstructive Apnea Hypopnea Index (AHI) >15 episodes per hour, or hypoventilation.
• Clinically significant parasomnias (eg, sleep walking, rapid eye movement [REM] sleep behavior disorder, etc).
• Periodic Limb Movement Disorder (PLMD) Arousal Index (PLMA-I) >15 during Screening PSG, a historical diagnosis of PLMD (last 10 years), or a PLMD diagnosis older than 10 years with current (last 60 days) treatment or symptoms of rhythmic movements involving one or both legs during sleep.
• Occupation requiring nighttime shift work or variable shift work with early work start times (before 6 AM), if this occurs more than once per week.
• Planned travel during the study that includes more than 3 time zones, or planned travel that includes 3 time zones on more than 2 occasions during the study.
• Going to sleep for the night later than 1 AM at a frequency of more than once per week.
• Current or past (within 1 year) major depressive episode according to DSM-5 criteria.
• Any history of attempted suicide (lifetime) or clinically significant suicidal ideation, in the opinion of the Investigator, based on the C-SSRS assessment at Screening.
• Any clinically significant unstable medical abnormality, chronic disease (eg, asthma or diabetes), or a history of a clinically significant abnormality of the cardiovascular, central nervous system,
• Any of the following out-of-range vital signs at Screening: systolic blood pressure outside 90-145 mmHg; diastolic blood pressure outside 50-90 mmHg; resting heart rate outside 40-100 beats per minute.
• History or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant, including the following:
• ECG findings of ischemia or infarct
• Complete bundle branch blocks
• Symptomatic arrhythmias as ventricular arrhythmias (non- sustained ventricular tachycardia (VT), multifocal or frequent premature ventricular contractions), bundle branch block, axis deviation, or abnormal or any predominantly non-sinus- conducted rhythm.
• QTcF >450 msec for males or >470 msec for females, on Screening ECG.
• PR interval outside the range of 120 to 220 msec on Screening ECG
• Estimated glomerular filtration rate (GFR) at Screening <60 mL/min/1.73 m2.
• Malignant neoplastic disease requiring therapy within 2 years prior to Screening or during the study, or clinically relevant as judged by the Investigator.
• Uncontrolled thyroid disorder as evidenced by thyroid stimulating hormone (TSH) ≤0.8 x the lower limit of normal (LLN) or ≥1.25 x the upper limit of normal (ULN) for the reference laboratory at Screening.
• Laboratory value for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 x upper limits of normal (ULN).
• Excessive caffeine use during the 10 days prior to first dose of study drug or anticipated excessive use defined as >600 mg/day of caffeine during the treatment periods of the study.
• Treatment or planned treatment with prohibited medications (including medications that may affect daytime sleepiness and nighttime sleep) or unwilling to refrain from any prohibited medications. Treatment must have been discontinued 14 days or 5 half-lives, whichever is longer, prior to the first dose of study medication (and at least 30 days for sedating antidepressants; at least 14 days for CNS stimulants).
• Current or past (within 12 months prior to Screening) substance use disorder (including alcohol and psychoactive cannabinoids) according to DSM-5 criteria; current or past history of substance abuse treatment (including alcohol), or unwilling to refrain from substance use (including alcohol) during the study.
• Nicotine dependence that has an effect on sleep (eg, a subject who routinely awakens at night to smoke).

Where it is running

• Sleep Disorders Center Of Alabama — Birmingham, Alabama, United States
• Amr Daphne — Daphne, Alabama, United States
• Lakeview Clinical Research — Guntersville, Alabama, United States
• SOCAL Clinical Research — Huntington Beach, California, United States
• Stanford University — Redwood City, California, United States
• Sleep Medicine Specialists of California — San Ramon, California, United States
• SDS Clinical Trials, Inc — Santa Ana, California, United States
• Delta Waves, Inc. — Colorado Springs, Colorado, United States
• Saint Francis Sleep Allergy and Lung Institute LLC — Clearwater, Florida, United States
• New Generation of Medical Trials — Hialeah, Florida, United States
• Angels Clinical Research — Miami, Florida, United States
• Ivetmar Medical Group — Miami, Florida, United States
• Somnology Research Associates — Miami, Florida, United States
• Clinical Trial Services, Corp — Miami, Florida, United States
• Pasadena Center for Medical Research — St. Petersburg, Florida, United States
• Clinical Site Partners, LLC - Winter Park — Winter Park, Florida, United States
• Global Research Associates — Atlanta, Georgia, United States
• Neurotrials Research, Inc — Atlanta, Georgia, United States
• Clinical Research Institute - Stockbridge — Stockbridge, Georgia, United States
• The University of Kansas Medical Center Research Institution Inc. — Kansas City, Kansas, United States
• Mid-Atlantic Epilepsy and Sleep Center - Bethesda — Bethesda, Maryland, United States
• Neurocare, Inc. — Newton, Massachusetts, United States
• Western Michigan University Homer Stryker Md School of Medicine — Kalamazoo, Michigan, United States
• Henry Ford Health - Columbus — Novi, Michigan, United States
• Clinical Neurophysiology Services PC — Sterling Heights, Michigan, United States

Full record on ClinicalTrials.gov

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