Do you have idiopathic hypersomnia? Consider the INTUNE study.
About the INTUNE study
The INTUNE study is evaluating the safety and efficacy of an investigational study drug, pitolisant, in adults with idiopathic hypersomnia (IH).
In the INTUNE study, researchers will evaluate the safety and efficacy of the study drug compared to a placebo for excessive daytime sleepiness and other symptoms in adults with IH. A placebo is a tablet that looks like the study drug but has no study drug in it.
Adults (18 years of age or older) who meet the following criteria may be eligible to participate:
- Diagnosed with IH
- Able to give informed consent
- Have excessive daytime sleepiness as measured by sleepiness questionnaires
- Are not pregnant, and do not plan to get pregnant or breastfeed during the study
This is not a complete list of study requirements. The study doctor will review all the requirements with you.
Study site locations
Find the INTUNE study site nearest you
Assistance with study-related travel expenses may be available to eligible participants. Even if there is no study site nearby, you may still be able to participate.
FAQs
Why should I take part in this study?
Clinical studies (also called clinical trials) are important for medical advances. Current treatments for diseases are only available because of clinical study volunteers.
Why is this study important?
This clinical study is being conducted by a pharmaceutical company as part of its research to learn more about an investigational drug in adults with IH. Study volunteers can help in this important research. Thank you for considering participating in this study.
What is the purpose of this study?
In the INTUNE study, researchers will evaluate the safety and efficacy of an investigational study drug, pitolisant, for excessive daytime sleepiness and other symptoms in adults with IH.
What can I expect if I decide to participate?
After a 28-day screening period, all eligible participants will receive daily doses of the study drug, pitolisant, for 8 weeks. After the 8-week period, study staff will evaluate participants to confirm eligibility to participate in the 4-week double-blind, randomized withdrawal phase. During this phase, study participants will either receive daily doses of the study drug or placebo. A placebo is a tablet that looks like the study drug but has no study drug in it. Neither the study participant, the study doctor, nor the Sponsor will know if the participant is receiving the study drug or placebo.
Participants will be in the study for up to approximately 4-5 months and will need to come to the study center 5 times. There are also 7 telephone calls that will take place during the study. After the final study visit, participants will have the opportunity to participate in an additional long-term safety study. If a participant chooses not to participate in the long-term safety study, they will have 2 safety follow-up telephone calls approximately 15 days and 30 days after the last dose of study drug.
Lab tests, physical exams, other assessments and questionnaires will be conducted as part of the study.
What are my costs to take part in this study?
You do not have to pay for the study drug, study supplies, or tests that are part of the clinical study.
Learn More
Download the Study Brochure
The Study Brochure provides detailed information for potential participants, including study requirements, visits and study length.
Download the Study Fact Sheet
The Study Fact Sheet provides “at a glance” information about the study for potential participants.
About clinical studies
What is a clinical study?
In a clinical study, participants are assigned to one or more study drugs to learn more about the study drug, to find out if it works or works better than other treatments, and to help researchers learn more about its potential side effects.
What is a study drug?
A study drug is a substance that is being tested in clinical studies. It is sometimes called an investigational drug. An ethics committee has reviewed the clinical study for testing in people and the study drug may or may not be approved by the government health agency for treatment for the condition being studied.
