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ALKS 2680-301 Idiopathic Hypersomnia

Applies To

Sleep Disorders

Date Published

Status

Open

An Open-Label, Long-Term Extension Study to Investigate the Safety, Tolerability, and Durability of Treatment Effect of ALKS 2680 in Participants With Narcolepsy Type 1 and Type 2 and Idiopathic Hypersomnia

Who can take part?

You may be able to take part if you have idiopathic hypersomnia (IH) and have completed a previous ALKS 2680 study.

You may be eligible if you:

  • Completed the ALKS 2680-203 study (Part A or Part B) and attended the end-of-treatment visit
  • Are willing and able to stop current IH medications during the study (as advised by the study doctor)

You may not be eligible if you:

  • Developed a new significant health issue during the previous study (including abnormal test results or eye/vision findings), or need planned eye surgery
  • Have a medical condition that could make participation unsafe or affect study results
  • Are pregnant, breastfeeding, or planning a pregnancy during the study
  • Are considered unsuitable by the study doctor

What is the study about?

This study is looking at ALKS 2680 (alixorexton), an investigational medication that targets the body’s sleep–wake system to help reduce excessive daytime sleepiness.

This is an open-label study, which means:

  • You will receive the active study medication
  • You and the study doctor will know which dose you are taking

You will stay on the same dose you received in the previous study.

What is involved?

  • Duration: up to 5 years
  • Clinic visits: 18 visits
  • Phone calls: up to 46 calls

Study medication may be:

  • Delivered to your home, or
  • Collected from the clinic

The study includes:

  • Screening period (up to 4 weeks)
  • Treatment period (about 240 weeks)
  • Follow-up period (4 weeks)

What will I need to do?

If you take part, you will:

  • Take study medication twice daily (tablets)
  • Attend clinic visits, including one overnight sleep study
  • Complete assessments such as:
    • Blood and urine tests
    • Heart tracing (ECG)
    • Questionnaires about sleep and daily activities
    • Activity monitoring

You will also stay in regular contact with the study team throughout the study.

More information

You can read more about this study here:

Apply for this Trial

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