Vibrance-2 Study Prescreening Questionnaire |
The purpose of this pre-screening survey is to see if you meet the criteria for taking part in our research study, called Vibrance-2. This phase 2 study will be conducted across multiple sites in collaboration with Alkermes Inc.
About the Vibrance-2 Study
This study will evaluate the safety and efficacy of the study medication, ALKS 2680, in patients with narcolepsy type 2 (NT2). ALKS 2680 is a selective orexin-2 receptor agonist that aims to restore orexin signaling and, thereby, promote wakefulness in patients with NT2.
If you decide to take part, you will be in the study for 12 - 21 weeks. All participants will have a total of 14 visits (up to 19 visits) with the study doctor or study team, including 2 overnight visits at Stanford Sleep Medicine Center in Redwood City. Some of these visits will be virtual using phone and/or video calls (telemedicine).
During this study:
- You will need to stop taking all medications prescribed for the management of narcolepsy symptoms (e.g., EDS) starting at least 2 weeks before Day 1 and throughout the treatment period
- You will be asked to answer questionnaires, give blood samples, and complete physical examinations with measurement of vital signs
- You will have the option to continue to the 5-week open label extension period following the 8-week randomized treatment period
Are you interested in taking part?
We are looking for people who are 18 - 70 years of age and have a diagnosis of narcolepsy type 2 (confirmed by diagnostic evaluations).
What else do I need to consider?
- The study team will explain the possible benefits and risks
- If you choose to take part, you can stop at any time
- You may be reimbursed for study visits to cover travel costs and other study-related costs
- You will receive all study medications and study-related tests at no charge.
- A team of medical staff will monitor your health carefully during the study
Your research study participation will contribute to information about ALKS 2680 and may benefit people receiving care for narcolepsy in the future.
If you are interested in taking part, please complete the pre-screening questionnaire below to see if you are eligible to participate. This will take approximately 5 minutes. You will go through a list of questions. You may choose not to answer these questions. You also may choose to stop participating at any time.
Information about you that you provide for this screening will be kept as confidential as possible as required by law. It is possible that the Food and Drug Administration, and other federal and state authorities, may inspect this record.
You can choose if you want or do not want to take part in this research screening procedure - it is up to you. If you refuse to answer the questions or stop answering them at any time, there will be no penalty, and you will not lose any benefits to which you otherwise would be entitled.
The risk to taking part in this questionnaire is very small and it is not designed to ask you for sensitive personal information. Your responses will be recorded; this will be kept confidential, but there is a small risk that people outside of the research team could learn this information. If you are not interested in the study, then your responses will be destroyed and securely disposed of.
The benefit to you of taking part in this questionnaire is that you will find out whether you can take part in this study.
You will not be paid for answering questions in this survey since it is only to see whether you qualify to take part in the study.
If you have any questions, concerns, or complaints about this interview, contact Emmanuel Mignot at 650-723-5879. If you want to talk to someone separate from the research team about a concern or complaint or your rights as a possible research subject, please contact the Stanford Institutional Review Board (IRB) to speak to an informed person who is separate from the research team 1-866-680-2906.
Please complete the survey below to see if you are eligible to participate in this study.
Thank you!