Idiopathic Hypersomnia: OnStride Study
Idiopathic Hypersomnia (IH) is a sleep disorder that causes excessive daytime sleepiness, making it difficult to stay awake and alert throughout the day
This clinical research study is evaluating the safety and effectiveness of an investigational medication (HBS-301) designed to improve wakefulness and reduce symptoms of excessive sleepiness. This medication is a new formulation of an FDA-approved treatment for narcolepsy and is designed to work more efficiently in the body, potentially helping with morning sleepiness while reducing the risk of sleep disruption at night.
Schedule of Activities:
Study duration is 16 weeks. For participants who enter the Open-Label Extension Period, the study duration is expected to be about 12 months.
- Clinic Visits: 4
- Telehealth Visits: 8
- Screening Period: 4 weeks
- Treatment Period: 8 weeks
- Optional OLE: 12 months
- Safety follow-up period: 4 weeks