Arise 2 - A Study of Oral BTD-001 in Adults With Idiopathic Hypersomnia

  • STATUS
    Recruiting
Updated on 23 November 2020
hypersomnia

Summary

This is a randomized, placebo-controlled, double-blind, crossover study of oral BTD-001 in adults with Idiopathic Hypersomnia.

 

Description

Stimulant use is allowed if certain criteria are met. 4 or 5 non-consecutive overnight sleep tests may be required.

Details
Condition Idiopathic Hypersomnia, Sleep Disorders, Sleep Disorders (Pediatric)
Clinical Study IdentifierTX225024
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female 18 to 70 years of age
No use of a CPAP machine when you sleep at night
Must have a historic overnight sleep test
Must sleep at least 7 hours on average per night
No history of another disorder causing hypersomnia other than Idiopathic Hypersomnia
No history of or current seizure disorder
A brief online pre-screening tool is available here: https://www.hypersomniastudy.com
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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