A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

September 11, 2026 updated by: Harmony Biosciences Management, Inc.

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) Followed by an Open-label Extension

This is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo-controlled clinical study to assess the efficacy and safety of HBS-301 in adult participants (ages ≥18 years) with idiopathic hypersomnia (IH).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Approximately 248 participants are planned for randomization in the study. The study will consist of a Screening/Baseline Period (up to 28 days), a Double-blind Treatment Period (8 weeks), an optional Open-label Extension (OLE) Period (1 year), and 30 days of safety follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
248

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Markham, Ontario, Canada, M5S 3A3
        • Recruiting
        • AMNDX Inc
        • Principal Investigator:
          • Alan Lowe
        • Contact:
      • Toronto, Ontario, Canada, M5S 3A3
        • Recruiting
        • Jodha Tishon Inc
        • Principal Investigator:
          • Colin Shapiro
        • Contact:
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35213
        • Recruiting
        • Sleep Disorders Center of Alabama
        • Contact:
        • Principal Investigator:
          • Robert Doekel
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Phoenix Medical Group LLC
        • Principal Investigator:
          • Robert Orr
        • Contact:
    • California
      • Redwood City, California, United States, 94063
        • Recruiting
        • Stanford Center for Sleep Medicine
        • Principal Investigator:
          • Oliver Sum-Ping, MD
        • Contact:
      • San Ramon, California, United States, 04583
        • Recruiting
        • Trial Site Solutions
        • Contact:
        • Principal Investigator:
          • Haramandeep Singh
      • Santa Monica, California, United States, 90404
        • Recruiting
        • Santa Monica Clinical Trials
        • Principal Investigator:
          • Daniel Norman, MD
        • Contact:
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Recruiting
        • Alpine Clinical Research Center, Inc.
        • Contact:
        • Principal Investigator:
          • John Harsh
      • Colorado Springs, Colorado, United States, 80918
        • Recruiting
        • Delta Waves LLC
        • Principal Investigator:
          • Jonathan Olin
        • Contact:
    • Florida
      • Miami, Florida, United States, 33176
        • Recruiting
        • PharmDev Research Institute, LLC
        • Principal Investigator:
          • Edward Mezerhane, MD
        • Contact:
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Central Florida Pediatric Sleep Disorders Institute (Florida Pediatric Research Institute, LLC)
        • Principal Investigator:
          • Akinyemi Ajayi
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • NeuroTrials Research Inc.
        • Principal Investigator:
          • Dennis Lacey, MD
        • Contact:
      • Macon, Georgia, United States, 31210
        • Recruiting
        • Sleep Practitioners, LLC
        • Principal Investigator:
          • Charles Wells
        • Contact:
      • Rincon, Georgia, United States, 31326
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Clinical Research Institute Stockbridge
        • Principal Investigator:
          • Phillip Nowlin
        • Contact:
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Recruiting
        • Fort Wayne Neurological Center
        • Principal Investigator:
          • James Stevens
        • Contact:
    • Michigan
      • Southfield, Michigan, United States, 48975
        • Recruiting
        • Revive Research Institute
        • Principal Investigator:
          • Syed Muhammad Talib Rizvi Raza, MD
        • Contact:
      • Sterling Heights, Michigan, United States, 48314
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Recruiting
        • St. Luke's Hospital, Sleep Medicine and Research Center
        • Principal Investigator:
          • Michael McLeland, PhD
        • Contact:
    • North Carolina
      • Gastonia, North Carolina, United States, 28054
        • Recruiting
        • Clinical Research of Gastonia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anup Banerjee, MD
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Stern Research Partners, LLC
        • Principal Investigator:
          • Thomas Stern, MD
        • Contact:
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • David Kudrow, MD
        • Principal Investigator:
          • David Kudrow
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Neuroscience Research Center, LLC
        • Principal Investigator:
          • Ryan Drake
        • Contact:
      • Cincinnati, Ohio, United States, 45245
        • Recruiting
        • Intrepid Research
        • Principal Investigator:
          • Bruce Corser
        • Contact:
    • Oklahoma
      • Ardmore, Oklahoma, United States, 73401
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Recruiting
        • Abington Neurological Associates
        • Principal Investigator:
          • John Khoury
        • Contact:
      • West Chester, Pennsylvania, United States, 19380
        • Recruiting
        • Suburban Research Associates
        • Principal Investigator:
          • Omer Abdullah, MD
        • Contact:
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • Berks Schuylkill Respiratory Specialists
        • Contact:
        • Principal Investigator:
          • Alec Platt, MD
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Recruiting
        • Infinity Medical Research Inc.
        • Principal Investigator:
          • Curtis Mello
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Recruiting
        • Lowcountry Lung and Critical Care, PA
        • Contact:
        • Principal Investigator:
          • Thomas Kaelin
      • Columbia, South Carolina, United States, 29201
        • Recruiting
        • Bogan Sleep Consultants, LLC
        • Contact:
        • Principal Investigator:
          • Richard Bogan
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • K2 Medical Research
        • Principal Investigator:
          • Joshua Lennon, MD
        • Contact:
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Aayus Research
        • Contact:
        • Principal Investigator:
          • Bhavim Desai
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Southwest Family Medicine Associates
        • Principal Investigator:
          • Chrisette Dharma
        • Contact:
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Metroplex Pulmonary and Sleep Center
        • Principal Investigator:
          • Shahrukh Kureishy
        • Contact:
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • HAS Research
        • Principal Investigator:
          • Hernan A Salazar, DO
        • Contact:
      • San Antonio, Texas, United States, 30328
        • Recruiting
        • Sleep Therapy and Research Center
        • Principal Investigator:
          • Nagwa Lamaie
        • Contact:
      • Sugar Land, Texas, United States, 77478
        • Recruiting
        • Tricoastal Narcolepsy and Sleep Disorders Center
        • Principal Investigator:
          • Gerry Meskill
        • Contact:
    • Virginia
      • Williamsburg, Virginia, United States, 23188
        • Recruiting
        • TPMG Clinical Research
        • Contact:
        • Principal Investigator:
          • Richard Parisi
    • Washington
      • Spokane, Washington, United States, 99210
        • Recruiting
        • Washington State University Sleep and Performance Center
        • Principal Investigator:
          • Devon Hansen
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
          • Lauren Chase
          • Phone Number: 304-598-4000
        • Principal Investigator:
          • Mouhannad Azzouz
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • David Plante
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Has a current documented diagnosis of IH per the International Classification of Sleep Disorders, Third Edition (ICSD-3) or Text Revision (ICSD-3-TR) criteria with confirmatory polysomnogram (PSG) with multiple sleep latency test (MSLT; and if applicable, a 24-hour PSG report or an actigraphy report with sleep log) on file that led to the diagnosis and was completed within the last 10 years.
  • Has EDS.
  • Has moderate to very severe symptoms of IH.
  • If taking a permitted chronic concomitant medication or supplement, including nonprohibited antidepressants or wake-promoting agents, must be on a stable dose for at least 3 months prior to Screening and agree to continue at that stable dose for the Double-blind Treatment Period of the study. As-needed use of any treatment that could affect daytime sleepiness (including but not limited to stimulants, modafinil, and armodafinil) used on an as-needed basis is not permitted.

Exclusion Criteria:

  • Has hypersomnia due to another medical disorder.
  • Has a history of pitolisant use within 5 half-lives prior to Screening.
  • Has a primary diagnosis of psychiatric illness, including depression, that is not well controlled.
  • Has a history of moderate or severe hepatic impairment.
  • Has a body surface area (BSA)-corrected estimated glomerular filtration rate (eGFR) <60 mL/min.
  • Has a known history of long QT syndrome or any significant history of a serious abnormality of the electrocardiogram (ECG).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Double-Blind Treatment Period HBS-301
HBS-301 tablets administered once daily in the morning upon wakening
Drug: HBS-301 tablet
HBS-301 tablet
Other Names:
  • pitolisant delayed-release
Placebo Comparator: Double-blind Treatment Period Placebo
Matching placebo tablets administered once daily in the morning upon wakening
Drug: Placebo
Placebo tablet
Experimental: Open-label Extension Period HBS-301
HBS-301 tablets administered once daily in the morning upon wakening
Drug: HBS-301 tablet
HBS-301 tablet
Other Names:
  • pitolisant delayed-release

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in severity of EDS as measured by the Epworth Sleepiness Scale (ESS)
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The ESS is an 8-item, 4-point rating scale.
Baseline to the end of the Double-blind Treatment Period (8 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in cognitive complaints as measured by the British Columbia Cognitive Complaints Inventory
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The British Columbia Cognitive Complaints Inventory is a participant-reported, 6-item, 4-point scale that assesses perceived cognitive difficulties.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Change in severity of IH symptoms as measured by the Idiopathic Hypersomnia Severity Scale (IHSS)
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The IHSS is a 14-item questionnaire designed to measure IH symptoms.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Change in sleep inertia as measured by the Sleep Inertia Questionnaire (SIQ)
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The SIQ is a 22-item questionnaire that measures aspects of night and day sleep symptoms and the sleep inertia related to each.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Change in fatigue as measured by the Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The PROMIS-Fatigue-SF-7a is a 7-question, 5-point scale used to assess fatigue.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Change in severity of EDS as measured by the Epworth Sleepiness Scale
Time Frame: Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)
The ESS is an 8-item, 4-point rating scale.
Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)
Change in severity of IH symptoms as measured by the IHSS
Time Frame: Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)
The ESS is an 8-item, 4-point rating scale.
Baseline through Week 1 and Week 2 of the Titration Period (1 week and 2 weeks)
Change in severity of EDS as measured by the Clinical Global Impression of Severity (EDS)
Time Frame: Baseline to end of Double-blind Treatment Period (8 weeks)
The Clinical Global Impression of Severity (EDS) is a 5-item observer-rated scale that gauges the severity of a participant's EDS symptoms.
Baseline to end of Double-blind Treatment Period (8 weeks)
Change in severity of EDS as measured by the Patient Global Impression of Severity (EDS)
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Severity (EDS) is a participant-reported assessment that gauges the severity of a participant's EDS symptoms.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Improvement in severity of EDS as measured by the Patient Global Impression of Change (EDS)
Time Frame: End of the Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Change (EDS) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their EDS symptoms.
End of the Double-blind Treatment Period (8 weeks)
Change in severity of IH symptoms as measured by the Clinical Global Impression of Severity (IH)
Time Frame: Baseline to end of Double-blind Treatment Period (8 weeks)
The Clinical Global Impression of Severity (IH) is a 3-item observer-rated scale used to track IH symptom changes.
Baseline to end of Double-blind Treatment Period (8 weeks)
Change in severity of IH symptoms as measured by the Patient Global Impression of Severity (IH)
Time Frame: Baseline to end of Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Severity (IH) is a participant-reported assessment that gauges the severity of a participant's IH symptoms.
Baseline to end of Double-blind Treatment Period (8 weeks)
Improvement in severity of IH symptoms as measured by the Patient Global Impression of Change (IH)
Time Frame: Baseline to end of Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Change (IH) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their IH symptoms.
Baseline to end of Double-blind Treatment Period (8 weeks)
Change in severity of sleep inertia as measured by the Patient Global Impression of Severity (Sleep Inertia)
Time Frame: Baseline to end of Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Severity (Sleep Inertia) is a participant-reported assessment that gauges the severity of a participant's sleep inertia symptoms.
Baseline to end of Double-blind Treatment Period (8 weeks)
Improvement in severity of sleep inertia as measured by the Patient Global Impression of Change (Sleep Inertia)
Time Frame: End of the Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Change (Sleep Inertia) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their sleep inertia symptoms.
End of the Double-blind Treatment Period (8 weeks)
Change in severity of fatigue as measured by the Patient Global Impression of Severity (Fatigue)
Time Frame: Baseline of the end of the Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Severity (Fatigue) is a participant-reported assessment that gauges the severity of a participant's fatigue symptoms.
Baseline of the end of the Double-blind Treatment Period (8 weeks)
Improvement in severity of fatigue as measured by the Patient Global Impression of Change (Fatigue)
Time Frame: End of the Double-blind Treatment Period (8 weeks)
The Patient Global Impression of Change (Fatigue) is a participant-reported outcome used to evaluate the effectiveness of a treatment on their fatigue symptoms.
End of the Double-blind Treatment Period (8 weeks)
Change in health-related quality of life as measured by the Short Form Health Survey-36 physical and mental component summaries
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The Short Form-36 includes 36 questions across 8 health domains to measure a participant's functional health and well-being.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Change in work productivity as measured by the Work Productivity and Activity Impairment: Idiopathic Hypersomnia Work Productivity loss score
Time Frame: Baseline to the end of the Double-blind Treatment Period (8 weeks)
The Work Productivity and Activity Impairment: Idiopathic Hypersomnia questionnaire is a 6-item scale used to measure impairments over 7 days.
Baseline to the end of the Double-blind Treatment Period (8 weeks)
Incidence of treatment-emergent adverse events
Time Frame: Throughout study (16 months including OLE)
A treatment-emergent adverse event is any adverse event reported after the first dose of study drug and up to 30 days after final dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug and up to 30 days after final dose of study drug.
Throughout study (16 months including OLE)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harmony Biosciences Management, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Seiden, MD, Harmony Biosciences Management, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HBS-301-CL-302
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523822-42-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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