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RESPIRATORY RESEARCH
SLEEP RESEARCH
SLEEP/RESPIRATORY RESEARCH
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About the study
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Narcolepsy and Idiopathic Hypersomnia are sleep disorders that cause individuals to be excessively sleepy during the day. Orexin agonists are an emerging class of small molecules that increase levels of orexin in the brain. In Narcolepsy there is an absence or lower level of orexin in the brain and some people with Narcolepsy or Idiopathic Hypersomnia may have problems with orexin signaling. These orexin issues are known to be responsible for excessive sleepiness and cataplexy symptoms. This clinical trial aims to understand the effects of the experimental medication ALKS 2680 (an orexin agonist) in people with Narcolepsy (with and without cataplexy) and Idiopathic Hypersomnia.
Eligibility Requirements
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Aged 18 – 65; BMI 18 – 45; NT1, NT2 or IH diagnosis; No OSA; No current smokers; Must not be pregnant, breastfeeding or planning a pregnancy; No ECG or liver function abnormalities; Note: this is a summary and a complete list of inclusion and exclusion criteria is available on request.
Chief Investigator:
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Ethics Approvals:
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What's Involved
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You will be provided with a complete participant information sheet and will have the opportunity to discuss the study with doctors prior to making any decisions about enrolling in this trial. If you are eligible for this study you will be asked to attend a screening visit and sign a consent form after speaking with one of the study doctors. If you are eligible to continue you will be asked to discontinue any medications used for Narcolepsy or Cataplexy under the guidance of a study doctor. The washout will begin about 2 weeks before the first study drug dosing and will continue until the last day of your clinical stay (total time of medication washout approx. 3-4 weeks). Your study doctor can help you develop a strategy for managing symptoms. During the 10 day stay, participants will receive three different doses of ALKS 2680 and one dose of matching placebo across 4 separate dosing days. On dosing days, participants will undergo Maintenance of Wakefulness Tests (MWTs), have blood samples taken, complete questionnaires and have other clinical assessments (e.g. ECG, blood pressure). A complete list of procedures will be available in the participant information sheet.
Find out more
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Contact name:
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Call:
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Email:
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Person Diagnosis
No
Person Diagnosis
Yes
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