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Idiopathic HypersomniaPhase 2NCT05668754

Study of SDX in Patients With Idiopathic Hypersomnia (IH)

A Phase 2 study testing Serdexmethylphenidate in people with Idiopathic Hypersomnia, run by Zevra Therapeutics at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Idiopathic Hypersomnia
What is being tested?
Serdexmethylphenidate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
41 sitesUnited States
Study dates
28 Dec 2022to 21 Mar 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 26Show fewer
  • 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).
  • Evidence of substance or alcohol use or has a positive urine or breath alcohol or positive urine drug screen at Screening.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • Global Research Associates

    Atlanta, Georgia, 30303

  • Neurotrials Research, Inc

    Atlanta, Georgia, 30303

  • Futuresearch Trials Of Neurology

    Austin, Texas, 78701

  • Mid-Atlantic Epilepsy and Sleep Center - Bethesda

    Bethesda, Maryland, 20817

  • Sleep Disorders Center Of Alabama

    Birmingham, Alabama, 35201

  • Medical University Of South Carolina (MUSC) - Institute Of Psychiatry (IOP)

    Charleston, South Carolina, 29401

  • Intrepid Research

    Cincinnati, Ohio, 45202

  • Saint Francis Sleep Allergy and Lung Institute LLC

    Clearwater, Florida, 33755

  • Delta Waves, Inc.

    Colorado Springs, Colorado, 80903

  • University of Missouri School Of Medicine

    Columbia, Missouri, 65211

  • Bogan Sleep Consultants

    Columbia, South Carolina, 29201

  • Amr Daphne

    Daphne, Alabama, 36526

  • Ohio Sleep Medicine Institute

    Dublin, Ohio, 43017

  • Dfw Clinical Research Associates

    Fort Worth, Texas, 76244

  • Clinical Research of Gastonia (CRG)

    Gastonia, North Carolina, 28052

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • New Generation of Medical Trials

    Hialeah, Florida, 33010

  • Houston Clinical Research Associates

    Houston, Texas, 77002

  • SOCAL Clinical Research

    Huntington Beach, California, 92647

  • Western Michigan University Homer Stryker Md School of Medicine

    Kalamazoo, Michigan, 49007

  • The University of Kansas Medical Center Research Institution Inc.

    Kansas City, Kansas, 64106

  • Barrett Clinic

    La Vista, Nebraska, 68128

  • Global Medical Institutes LLC- Princeton Medical Institute

    Lawrence, New Jersey, 08648

  • Brian Abaluck, LLC

    Malvern, Pennsylvania, 19355

  • Angels Clinical Research

    Miami, Florida, 33122

  • Ivetmar Medical Group

    Miami, Florida, 33130

  • Somnology Research Associates

    Miami, Florida, 33130

  • Clinical Trial Services, Corp

    Miami, Florida, 33144

  • Neurocare, Inc.

    Newton, Massachusetts, 02459

  • Henry Ford Health - Columbus

    Novi, Michigan, 48375

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Stanford University

    Redwood City, California, 94063

  • Sleep Therapy & Research Center

    San Antonio, Texas, 78205

  • Sleep Medicine Specialists of California

    San Ramon, California, 94583

  • SDS Clinical Trials, Inc

    Santa Ana, California, 92701

  • Clayton Sleep Institute, Llc

    St Louis, Missouri, 63123

  • Pasadena Center for Medical Research

    St. Petersburg, Florida, 33707

  • Clinical Neurophysiology Services PC

    Sterling Heights, Michigan, 48313

  • Clinical Research Institute - Stockbridge

    Stockbridge, Georgia, 30281

  • TPMG Clinical Research - Williamsburg

    Williamsburg, Virginia, 23185

  • Clinical Site Partners, LLC - Winter Park

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Phase 2, Placebo-Controlled, Double-Blind, Randomized Withdrawal Study to Determine the Safety and Efficacy of Oral SDX in Patients With Idiopathic Hypersomnia (IH)

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

Read the detailed description

SDX is a prodrug of dexmethylphenidate (d-MPH). SDX behaves as a prototypical prodrug that is devoid of pharmacological effects until metabolized to active d-MPH. Central nervous system (CNS) stimulants, including d-MPH products, are being used off-label by patients with IH. The potential advantage of SDX-derived d-MPH is its unique PK profile with rising d-MPH plasma concentrations at approximately 3 hours postdose followed by a broad peak from approximately 8 to 12 hours postdose (without sharp exposure spikes), and a gradual decline after the peak.

The optimal dose of SDX will be determined for each participant by titration based on individual tolerability and response during the 5-week SDX-only Open-Label Titration period (OLTP), after which 2/3 of the participants will continue to receive SDX and 1/3 of the participants will receive placebo (withdrawal design) in the 2-week Double-Blind Withdrawal Period (DBWP).

The study will evaluate safety (primary endpoint), efficacy and PK in patients with IH after daily oral administration of SDX either once per day in the evening (qd pm) or twice per day (morning and evening: bid). The study is expected to inform about the optimal SDX dose range and the best dose regimen (nighttime dosing or twice-per-day) for further studies in patients with IH and narcolepsy. The evening dosing regimen (just before bedtime) is of interest since there is little or no exposure to d-MPH for the first several hours post-dose and the mean peak d-MPH concentration occurs at 10-12 hours post-dose (ie, in the morning after a nighttime dose).

Being tested
Serdexmethylphenidate, Placebo
Keywords
Disorders of Excessive Somnolence, Sleep Disorders, Intrinsic Dyssomnias, Sleep Wake Disorders, Nervous System Diseases, Mental Disorders
Medical subject headings
Idiopathic Hypersomnia, Disorders of Excessive Somnolence, Sleep Wake Disorders, Nervous System Diseases, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SerdexmethylphenidateDrug

    Also called SDX

    Participants randomized to active drug will receive their optimized dose according to a dosing regimen set by randomization at the start of the OLTP. The 4 possible oral SDX doses are 80, 160, 240, or 320 mg/day. The optimal SDX dose will be determined during the 5-week OLTP preceding the 2-week DBWP.

  • PlaceboOther

    Participants randomized to placebo will receive matching placebo capsules to the optimized dose established at the end of the OLTP, according to a dosing regimen set by randomization at the start of the OLTP.

Study groups in NCT05668754
Study groupRoleWhat they receive
Experimental: SDXExperimentalSDX capsules at the optimized daily dose, once in the evening daily (qd pm) or twice per day (bid), for 2 weeks (Double-Blind Withdrawal Period)
Receives: Drug: Serdexmethylphenidate
Placebo ComparatorPlacebo comparatorPlacebo capsules once in the evening daily (qd pm) or twice per day (bid), for 2 weeks (Double-Blind Withdrawal Period)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Epworth Sleepiness Scale (ESS) Score

    Scores level of daytime sleepiness ranging from 0 to 24, with a higher score indicating worsened sleepiness

    Measured: Start to end of DBWP (2 weeks)

Secondary outcomes (1)

  1. Change From Baseline in Epworth Sleepiness Scale (ESS) Score

    Scores level of daytime sleepiness ranging from 0 to 24, with a higher score indicating worsened sleepiness

    Measured: Changes from Titration Baseline to Week 5 (5 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start28 Dec 2022
  3. Primary completion28 Feb 2024
  4. Study completion21 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 2, placebo-controlled, double-blind, randomized withdrawal study to determine the safety and efficacy of oral SDX in patients with Idiopathic Hypersomnia (IH).
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668754
Sponsor's protocol ID
KP1077.D01
Status last verified
Jun 2026
First submitted
19 Dec 2022
Last updated
30 Jun 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: None planned

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serdexmethylphenidate in people with Idiopathic Hypersomnia, run by Zevra Therapeutics at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Epworth Sleepiness Scale (ESS) Score (time frame: Start to end of DBWP (2 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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