It’s a new day for research in Narcolepsy (Type 1 & 2) and Idiopathic Hypersomnia (IH)

Narcolepsy and Idiopathic Hypersomnia (IH) are rare conditions that make people feel very sleepy during the day. This is often referred to as excessive daytime sleepiness (EDS). People living with EDS feel a strong urge to sleep during the day, even in situations where they should be awake and alert. This makes it harder to focus while at school, work, or while driving.

The CRYSTAL-1 study is a phase 2 clinical trial testing a potential treatment to see if it can help people with sleep-wake disorders like Narcolepsy and IH. The study is open to people ages 18 to 65 who have been diagnosed with or have symptoms consistent with Narcolepsy or IH and are willing to stop taking their current medications for these conditions.

Narcolepsy and Idiopathic Hypersomnia have a BIG impact on the smallest activities.

Additional inclusion and exclusion criteria may apply

What is Narcolepsy?

Narcolepsy is a rare, lifelong disorder that affects the brain’s ability to regulate sleep and wakefulness. There are two types:

  • People with Narcolepsy Type 1 (NT1) experience excessive daytime sleepiness (EDS), disturbed nighttime sleep, and a symptom called cataplexy. Cataplexy causes a sudden loss of muscle strength, which can cause someone to fall or lose control of their muscles for a short time. This is often triggered by strong emotions, such as laughter or surprise.

  • People with Narcolepsy Type 2 (NT2) experience excessive daytime sleepiness (EDS) and disturbed nighttime sleep, just like NT1, but they do not have cataplexy—a symptom that causes a sudden loss of muscle strength.

What is Idiopathic Hypersomnia (IH)?

Idiopathic Hypersomnia (IH) is another lifelong sleep disorder that causes extreme sleepiness. People with IH may sleep for long hours at night but still feel tired during the day. They often struggle to wake up and may experience “brain fog”—feeling confused, slow thinking, or forgetful. Unlike Narcolepsy, IH does not cause sudden muscle weakness while awake, known as cataplexy.

About CRYSTAL-1 Investigational Drug

Orexin is a protein in the brain that helps to coordinate a system that plays an important role in helping us stay awake. In this way, orexin is like the ‘conductor of the orchestra’ for keeping us awake.

An investigational drug is being researched in this study that is designed to mimic the action of orexin. This investigational drug may help people with Narcolepsy and Idiopathic Hypersomnia (IH) feel more awake and improve daily functioning.

Participants will take the investigational drug by mouth with water. After taking each dose, they must wait one hour before eating.

About the CRYSTAL-1 Study

Currently, there is no cure for Narcolepsy or Idiopathic Hypersomnia (IH) and these conditions often go undiagnosed due to symptoms of excessive daytime sleepiness (EDS) being common in other conditions.

The CRYSTAL-1 study is evaluating whether the investigational drug can help improve symptoms of excessive daytime sleepiness (EDS) and overall functioning. The study is also investigating other effects the investigational drug may have in the body.

Eligible participants will be randomly assigned (by chance) to a group to receive either the investigational drug or placebo (looks like the investigational drug but contains no active ingredients). Participants, the study doctor, and the study staff will not know to which group participants are assigned.

Every 14 days, participants may be switched between the investigational drug and placebo. For example, participants might receive the investigational drug for 14 days and then placebo for the next 14 days. All participants will receive a total of 28 days of the investigational drug and 14 days of placebo.

Eligibility Criteria

You may be eligible for this study if you:

  • Are diagnosed with or have symptoms consistent with Narcolepsy or IH

  • Are between the ages of 18 and 65

  • Are willing to discontinue all medications used for the treatment of Narcolepsy and IH

  • Are willing to complete an evaluation involving medical tests and assessments

You are not eligible for this study if you:

  • Have a medical condition other than Narcolepsy or IH that causes excessive daytime sleepiness (EDS)

  • Use positive airway pressure, such as a CPAP machine, for any reason

  • Currently smoke (this includes cigarettes, vaping, nicotine gum or patches)

  • Have a history of seizure disorder, stroke, or heart disease

  • Have a history of schizophrenia, bipolar disorder or are currently experiencing symptoms of depression

Additional inclusion and exclusion criteria may apply

This study is divided into four main periods:

  • Screening Period (up to 45 days): Doctors check your health and symptoms to see if you qualify. You also stop taking any current medications for Narcolepsy or IH. 

  • Baseline Period: You have tests to assess your symptoms while you are off your medications. 

  • Treatment Period (up to 42 days): You take the study drug or placebo and have scheduled checkups.

  • Follow-Up (7 days after treatment ends): Doctors conduct your final health assessment.

What Will Happen in This Study

1. Screening Visit

If you are interested in joining this study, you will need to visit one of the study centers nearest your home.

A study doctor will explain the study to you. If you agree to join, the doctor and site staff will check your overall health through simple tests and procedures. The study doctor will also ask you questions about your symptoms, medical history, and medication history to make sure you are eligible to take part in the study. During this period, you will need to discontinue all medications used for the treatment of Narcolepsy or IH. The screening period may last for up to 45 days.

2. Baseline Visit

If you meet all the criteria of the study and decide to join the study, you will come in for tests to assess your symptoms while you are off your medications.

3. Study Visit

During the Treatment Period, you may have study visits at the study site, or, if applicable, in your home through a home nursing service. The study visits may include overnight stays in the study center to complete assessments.

You will take the study drug or placebo capsules daily by mouth for up to 42 days and will also fill out an electronic diary throughout the study.

4. Follow-Up Visit

After you receive the final dose of study drug in the Treatment Period, you will return to the study center for a follow-up visit 7 days after your last dose of study drug. You can start taking the medications you were previously taking for the treatment of Narcolepsy or IH after this visit.

Interested in Learning More?

If you are interested in learning more about this study, please click the button below to see if you qualify or contact the Support Center.

Travel reimbursement may be available for you. More information can be provided by your site if you prequalify

Frequently Asked Questions

  • You may or may not benefit from taking part in this study. The knowledge gained from this study may help doctors learn more about the study drug and this may help future participants. It is possible that the study drug may improve your symptoms. However, you may receive no medical benefit, and the study drug may even be harmful to you.

  • The study drug and procedures will be made available to you at no charge. This study will require you to give up some of your time to make the planned study visits and may result in some extra travel costs compared with if you followed a standard treatment. Compensation and expense reimbursement are available, and your study doctor can answer any questions you may have.

  • Yes, you can. You are free to withdraw your consent and stop taking part in the study at any time without giving a reason.

  • An investigational drug is a medicine being tested to make sure it is safe and effective. The investigational drug in the CRYSTAL-1 study is not approved for use by the FDA or any other regulatory agency and is only available to people participating in this study.

This website is operated by ProofPilot, Inc.  All content is owned by Centessa Pharmaceuticals (UK) Limited. This website is intended for residents of the United States only. The investigational drug in the CRYSTAL-1 study is not approved for use by the FDA or any other regulatory agency and is only available to people participating in this study.