Seeking Participants for New Studies of Excessive Daytime Sleepiness

The Vibrance Studies are researching the safety and effectiveness of an investigational study drug taken orally once daily in adults 18–70 years of age for the potential treatment of excessive daytime sleepiness (EDS) symptoms in adults with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH).

Study Purpose

The purpose of the Vibrance Studies is to research an investigational study drug for the potential treatment of EDS in adults with NT1, NT2, or IH. The investigational drug is not approved for use by any health authority. Safety and effectiveness have not been established.

Study Design

Screening
Period

Treatment
Period

Open-Label Extension Period*

Safety Follow-Up Period

*This period only occurs in the Vibrance-1 and Vibrance-2 Studies.

Individuals with NT1 may be eligible for the Vibrance-1 Study, individuals with NT2 may be eligible for the Vibrance-2 Study, and individuals with IH may be eligible for the Vibrance-3 Study. During the studies, participants will be chosen at random to receive either the study drug or the placebo once daily. The Vibrance-1 and Vibrance-2 Studies will last up to 21 weeks with 19–21 visits over the course of the study, 9–12 of which will be done by telephone. The Vibrance-3 Study will last up to 16 weeks with approximately 14 visits, 6 of which will be done by telephone. In all 3 Vibrance Studies, 2 mandatory in-clinic overnight stays are required for all participants.

Eligibility Criteria

Key Inclusion Criteria

  • 18–70 years of age
  • Have residual EDS (i.e., Epworth Sleepiness Scale [ESS]) of > 10
  • Meet the diagnostic criteria of NT1 (Vibrance-1), NT2 (Vibrance-2), or IH (Vibrance-3)
  • Be willing and able to discontinue any medications for the management of narcolepsy or IH symptoms, including EDS, for at least 14 days (or 5 half-lives, whichever is longer)
  • Have a body mass index (BMI) ≥ 18 and ≤ 35 kg/m2
  • Be willing and able to understand and comply with protocol requirements

Key Exclusion Criteria

  • Has comorbid sleep disorder or condition that may influence the sleep/wake cycle
  • Has a significant cardiovascular disease during the screening period or within the past 2 years
  • Has a major psychiatric or substance use disorder
  • Is currently pregnant, breastfeeding, or is planning to become pregnant

Additional eligibility criteria apply.

Find a participating site

Vibrance Studies Research Sites

If you have a patient who you think may qualify, please refer your patient to VibranceStudies.com to take the prescreening questionnaire to determine their eligibility, or fill out a contact request form if you would like to request contact directly from an active research site. To determine the closest participating research sites for you to contact, enter a zip code.

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