ALKS 2680-203 Idiopathic Hypersomnia

A Phase 2, randomised, parallel-group, double-blind, dose-range-finding study to evaluate the safety and efficacy of ALKS 2680 in subjects with Idiopathic Hypersomnia

Who can take part?

You may be able to take part if you have idiopathic hypersomnia, a condition that causes excessive daytime sleepiness, difficulty waking, and ongoing tiredness.

You may be eligible if you:

• Are 18 to 70 years of age
• Have a confirmed diagnosis of idiopathic hypersomnia based on sleep studies
• Have significant daytime sleepiness
• Are able to stop current medications used to manage your symptoms for the duration of the study

You would not be able to take part if:

• You have another significant sleep disorder
• You are pregnant or breastfeeding
• The study doctor feels that participation may not be safe for you

What is involved?

This study is looking at whether ALKS 2680, an investigational medication that works on the body’s sleep–wake system, may help improve excessive sleepiness.

• Study duration: Approximately 15 weeks
• Clinic visits: 15 visits during the study
• Phone calls: Included as part of the visit schedule

The study includes:

• A screening period (2 to 5 weeks)
• A treatment period (8 weeks)
• A follow‑up period (2 weeks)

Participants who complete this study may have the option to continue into a longer-term extension study.

What will I need to do?

If you take part, you will be asked to:

• Take the study medication as a once-daily oral tablet
• Attend clinic visits, including overnight sleep studies
• Take part in assessments, which may include:
• • Blood tests
  • A heart tracing (ECG)
  • Eye (ophthalmology) checks
  • Questionnaires about your sleep and daily functioning
  • Cognitive (thinking and memory) assessments
  • Activity monitoring

You will also have regular contact with the study team throughout the study.

More information

You can read more about this study here:

• ClinicalTrials.gov – ALKS 2680 Study