Boulder, CONCT07500090Now EnrollingIRB Ready

Idiopathic Hypersomnia Clinical Trial in Boulder, CO

Access cutting-edge idiopathic hypersomnia treatment through this clinical trial at a research site in Boulder. Study-provided care at no cost to qualified participants.

Sponsored by Harmony Biosciences Management, Inc.

Quick Self-Assessment

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Expert Care in Boulder

Access idiopathic hypersomnia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related idiopathic hypersomnia treatment provided free

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Check if you qualify for this idiopathic hypersomnia clinical trial in Boulder, CO

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Why Participate?

  • No-Cost Study Care

  • Local to Boulder

    Convenient for CO residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Boulder site if eligible
  4. 4Begin participation

About This Idiopathic Hypersomnia Study in Boulder

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).

Sponsor: Harmony Biosciences Management, Inc.

Who Can Participate

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 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).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boulder?

Yes, this clinical trial (NCT07500090) has an active research site in Boulder, CO that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Idiopathic Hypersomnia Treatment Options in Boulder, CO

If you're searching for idiopathic hypersomnia treatment options in Boulder, CO, this clinical trial (NCT07500090) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boulder research site is actively enrolling participants for this clinical trial. You'll receive care from experienced idiopathic hypersomnia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all idiopathic hypersomnia clinical trials near you to find additional studies recruiting in your area.

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