Clinical trial in the U.S. for adult patients with narcolepsy


PEACE is an expanded access program available to adults in the U.S. diagnosed with narcolepsy (type 1 or type 2).

  • If you qualify for the PEACE program you will be provided with pitolisant*, at no cost to you, to treat the symptoms of excessive daytime sleepiness (EDS) and/or cataplexy associated with narcolepsy.
  • Not everyone who wishes to take part in the PEACE program will be eligible; please refer to the key eligibility criteria below.

Key eligibility criteria

Aged 18 years of age and over

Diagnosis of narcolepsy with or without cataplexy (type 1 or type 2)

  • Pitolisant* may or may not be effective in treating your symptoms of EDS and/or cataplexy associated with narcolepsy and there may be risks associated with its use.
  • Talk to your treating physician about the possibility of taking part in the PEACE program and any side effects that you may experience.
  • Your physician will discuss potential side effects with you before obtaining your consent to participate in this program.
  • Patients participating in the PEACE program will only receive pitolisant* through a physician participating in the program.
  • To check to see if your physician is participating in the PEACE program, select the list of participating physicians.

What should I do next?

If you are interested in participating in the PEACE program, please follow these steps:

  1. Check the entry criteria to see if you may be able to participate
  2. Check the list of participating physicians to see if your physician is listed
    • If your physician is participating in the PEACE program, please speak to him/her directly about taking part in the program.
    • If your physician is not participating in the PEACE program, he/she will need to register before you can take part in the program.
  1. If your physician determines that you are eligible to take part in the PEACE program, you will be asked to sign an Informed Consent Form.

The Informed Consent Form provides details about the PEACE program, your rights as a participant, potential side effects and other information about pitolisant*. After you sign the form and have been enrolled in the program, your treating physician will advise you on the next steps and the anticipated timing for you to be able to start treatment with pitolisant*.

If you are already receiving pitolisant by other means (not through the PEACE program), you should consult with your physician first before stopping shipments, to ensure there is no interruption in your treatment.

*Pitolisant is an investigational medication in the U.S that is not currently approved by the Food and Drug Administration (FDA). Harmony Biosciences, LLC, in partnership with Bioprojet, will be submitting a New Drug Application to the FDA for the evaluation of the safety and effectiveness of pitolisant. Pitolisant was approved in Europe in March 2016 for the treatment of adult patients with narcolepsy with or without cataplexy (type 1 and type 2).

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