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Completed Phase 2 Interventional Results available

Study of SDX in Patients With Idiopathic Hypersomnia (IH)

ClinicalTrials.gov ID: NCT05668754

Public ClinicalTrials.gov record NCT05668754. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT05668754
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Zevra Therapeutics
Industry
Enrollment
66 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 28, 2022 (Actual)
Primary completion
Feb 28, 2024 (Actual)
Completion
Mar 21, 2024 (Actual)
Last update posted
Jun 30, 2026

2022 – 2024

United States locations

U.S. sites
41
U.S. states
18
U.S. cities
37
Facility City State ZIP Site status
Sleep Disorders Center Of Alabama Birmingham Alabama 35201 —
Amr Daphne Daphne Alabama 36526 —
Lakeview Clinical Research Guntersville Alabama 35976 —
SOCAL Clinical Research Huntington Beach California 92647 —
Stanford University Redwood City California 94063 —
Sleep Medicine Specialists of California San Ramon California 94583 —
SDS Clinical Trials, Inc Santa Ana California 92701 —
Delta Waves, Inc. Colorado Springs Colorado 80903 —
Saint Francis Sleep Allergy and Lung Institute LLC Clearwater Florida 33755 —
New Generation of Medical Trials Hialeah Florida 33010 —
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 —
Pasadena Center for Medical Research St. Petersburg Florida 33707 —
Clinical Site Partners, LLC - Winter Park Winter Park Florida 32789 —
Global Research Associates Atlanta Georgia 30303 —
Neurotrials Research, Inc Atlanta Georgia 30303 —
Clinical Research Institute - Stockbridge Stockbridge Georgia 30281 —
The University of Kansas Medical Center Research Institution Inc. Kansas City Kansas 64106 —
Mid-Atlantic Epilepsy and Sleep Center - Bethesda Bethesda Maryland 20817 —
Neurocare, Inc. Newton Massachusetts 02459 —
Western Michigan University Homer Stryker Md School of Medicine Kalamazoo Michigan 49007 —
Henry Ford Health - Columbus Novi Michigan 48375 —
Clinical Neurophysiology Services PC Sterling Heights Michigan 48313 —
University of Missouri School Of Medicine Columbia Missouri 65211 —
Clayton Sleep Institute, Llc St Louis Missouri 63123 —
Barrett Clinic La Vista Nebraska 68128 —
Global Medical Institutes LLC- Princeton Medical Institute Lawrence New Jersey 08648 —
Clinical Research of Gastonia (CRG) Gastonia North Carolina 28052 —
Intrepid Research Cincinnati Ohio 45202 —
Ohio Sleep Medicine Institute Dublin Ohio 43017 —
Brian Abaluck, LLC Malvern Pennsylvania 19355 —
Thomas Jefferson University Philadelphia Pennsylvania 19107 —
Medical University Of South Carolina (MUSC) - Institute Of Psychiatry (IOP) Charleston South Carolina 29401 —
Bogan Sleep Consultants Columbia South Carolina 29201 —
Futuresearch Trials Of Neurology Austin Texas 78701 —
Dfw Clinical Research Associates Fort Worth Texas 76244 —
Houston Clinical Research Associates Houston Texas 77002 —
Sleep Therapy & Research Center San Antonio Texas 78205 —
TPMG Clinical Research - Williamsburg Williamsburg Virginia 23185 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05668754, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 30, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05668754 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →