Adelaide Institute for Sleep Health (AISH) are running a trial to understand the effects of the experimental medication ALKS 2680 (an orexin agonist) in people with narcolepsy (without cataplexy) and Idiopathic Hypersomnia, at the Adelaide Institute for Sleep Health, Flinders University, South Australia.
Participants 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 (washout) used for narcolepsy 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 10-day 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.
Participants will be reimbursed for costs (including travel, meals and accommodation) and their time and involvement in this study.
You may be suitable to take part if you meet the following criteria:
- Aged 18 – 65
- Body Mass Index (BMI) 18 – 45
- Narcolepsy Type 2 (without cataplexy) or Idiopathic Hypersomnia diagnosis
- No significant Obstructive Sleep Apnoea
- Non smoker
- Must not be pregnant, breastfeeding or planning a pregnancy
- No ECG or liver function abnormalities
- Willing to travel to the Adelaide Institute for Sleep Health, Flinders University, South Australia (all costs to be covered)
Note: this is a summary and a complete list of inclusion and exclusion criteria is available on request.
If you are interested in participating in this study, please email firstname.lastname@example.org or call (08) 8201 7687 Alison Teare.
This research is being conducted by researchers at the Adelaide Institute for Sleep Health, Flinders University. The project is being sponsored by Alkermes, Inc, in collaboration with PPD Australia Pty Ltd. This project has been approved by the Bellberry Human Research Ethics Committee in accordance with the National Statement on Ethical Conduct in Human Research (2007 – incorporating all updates).