Could a new pill help people who feel sleepy all day?

NCT ID NCT05668754

Symptom relief Sponsor: Zevra Therapeutics Source: ClinicalTrials.gov ↗

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests an oral drug called SDX (serdexmethylphenidate) to see if it safely reduces excessive daytime sleepiness in adults with idiopathic hypersomnia, a condition where people feel extremely sleepy during the day despite getting enough sleep at night. Participants will first receive SDX for five weeks to find their best dose, then be randomly assigned to continue SDX or switch to a placebo for two weeks. The main goal is to measure changes in daytime sleepiness using a standard questionnaire.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Serdexmethylphenidate (SDX)
What this could lead to: If successful, this could point toward a new treatment option for managing excessive daytime sleepiness in people with idiopathic hypersomnia.
What could go wrong: This is a phase 2 trial with only 66 participants, so results may not apply to everyone. The drug may cause side effects or fail to show meaningful benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

66 people

The number who actually took part.

Started

Dec 2022

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 18 years of age at the time of consent 2. Body Mass Index (BMI) ≤35 kg/m2 3. Documented primary diagnosis of IH according to the International Classification of Sleep Disorders (ICSD-3) criteria 4. At the Screening Visit and Baseline Visit (start of OLTP), Epworth Sleepiness Scale (ESS) scores ≥11 5. Average nightly Total Sleep Time (TST) of ≥7 hours, per subject history and confirmed during screening. 6. 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. 7. 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. 8. 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. Exclusion Criteria 1. Hypersomnia due to another medical, behavioral, or psychiatric disorder condition (eg, narcolepsy, depression disorders, multiple sclerosis, Parkinson's disease, stroke). 2. 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. 3. Clinically significant parasomnias (eg, sleep walking, rapid eye movement \[REM\] sleep behavior disorder, etc). 4. 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. 5. 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. 6. 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. 7. Going to sleep for the night later than 1 AM at a frequency of more than once per week. 8. Current or past (within 1 year) major depressive episode according to DSM-5 criteria. 9. 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. 10. 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, 11. 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. 12. History or presence of abnormal ECGs, which in the Investigator's opinion is clinically significant, including the following: 1. ECG findings of ischemia or infarct 2. Complete bundle branch blocks 3. 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. 4. QTcF \>450 msec for males or \>470 msec for females, on Screening ECG. 5. PR interval outside the range of 120 to 220 msec on Screening ECG 13. Estimated glomerular filtration rate (GFR) at Screening \<60 mL/min/1.73 m2. 14. Malignant neoplastic disease requiring therapy within 2 years prior to Screening or during the study, or clinically relevant as judged by the Investigator. 15. 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. 16. Laboratory value for aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3 x upper limits of normal (ULN). 17. 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. 18. 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). 19. 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. 20. Nicotine dependence that has an effect on sleep (eg, a subject who routinely awakens at night to smoke). 21. Evidence of substance or alcohol use or has a positive urine or breath alcohol or positive urine drug screen at Screening.

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence idiopathic hypersomnia nervous system disorder psychiatric disorder sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic hypersomnia

Contacts and locations

Locations

Amr Daphne

Daphne, Alabama, 36526, United States
Angels Clinical Research

Miami, Florida, 33122, United States
Barrett Clinic

La Vista, Nebraska, 68128, United States
Bogan Sleep Consultants

Columbia, South Carolina, 29201, United States
Brian Abaluck, LLC

Malvern, Pennsylvania, 19355, United States
Clayton Sleep Institute, Llc

St Louis, Missouri, 63123, United States
Clinical Neurophysiology Services PC

Sterling Heights, Michigan, 48313, United States
Clinical Research Institute - Stockbridge

Stockbridge, Georgia, 30281, United States
Clinical Research of Gastonia (CRG)

Gastonia, North Carolina, 28052, United States
Clinical Site Partners, LLC - Winter Park

Winter Park, Florida, 32789, United States
Clinical Trial Services, Corp

Miami, Florida, 33144, United States
Delta Waves, Inc.

Colorado Springs, Colorado, 80903, United States
Dfw Clinical Research Associates

Fort Worth, Texas, 76244, United States
Futuresearch Trials Of Neurology

Austin, Texas, 78701, United States
Global Medical Institutes LLC- Princeton Medical Institute

Lawrence, New Jersey, 08648, United States
Global Research Associates

Atlanta, Georgia, 30303, United States
Henry Ford Health - Columbus

Novi, Michigan, 48375, United States
Houston Clinical Research Associates

Houston, Texas, 77002, United States
Intrepid Research

Cincinnati, Ohio, 45202, United States
Ivetmar Medical Group

Miami, Florida, 33130, United States
Lakeview Clinical Research

Guntersville, Alabama, 35976, United States
Medical University Of South Carolina (MUSC) - Institute Of Psychiatry (IOP)

Charleston, South Carolina, 29401, United States
Mid-Atlantic Epilepsy and Sleep Center - Bethesda

Bethesda, Maryland, 20817, United States
Neurocare, Inc.

Newton, Massachusetts, 02459, United States
Neurotrials Research, Inc

Atlanta, Georgia, 30303, United States
New Generation of Medical Trials

Hialeah, Florida, 33010, United States
Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States
Pasadena Center for Medical Research

St. Petersburg, Florida, 33707, United States
SDS Clinical Trials, Inc

Santa Ana, California, 92701, United States
SOCAL Clinical Research

Huntington Beach, California, 92647, United States
Saint Francis Sleep Allergy and Lung Institute LLC

Clearwater, Florida, 33755, United States
Sleep Disorders Center Of Alabama

Birmingham, Alabama, 35201, United States
Sleep Medicine Specialists of California

San Ramon, California, 94583, United States
Sleep Therapy & Research Center

San Antonio, Texas, 78205, United States
Somnology Research Associates

Miami, Florida, 33130, United States
Stanford University

Redwood City, California, 94063, United States
TPMG Clinical Research - Williamsburg

Williamsburg, Virginia, 23185, United States
The University of Kansas Medical Center Research Institution Inc.

Kansas City, Kansas, 64106, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
University of Missouri School Of Medicine

Columbia, Missouri, 65211, United States
Western Michigan University Homer Stryker Md School of Medicine

Kalamazoo, Michigan, 49007, United States

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