Narcolepsy and Hypersomnia IST with Xywav™
Jazz only supports study proposals that have a legitimate scientific purpose and take into account the importance of the study objectives to medical science and patient care and the ability of the study sponsor to deliver a high-quality ethical study. Submission of a proposal does not imply or guarantee approval.
Xywav™ (calcium, magnesium, potassium, and sodium oxybates)
- Research to improve understanding of the burden of idiopathic hypersomnia, including impact on quality of life, and social, academic, and occupational functioning
- Research to help elucidate long-term health consequences associated with narcolepsy and idiopathic hypersomnia
- Research to examine the impact of oxybate treatment on cognition, functional performance, and total sleep time
- Research to evaluate sleep architecture in IH
Jazz has a two-stage review process: concept and protocol review. After you submit your concept proposal, our Review Committee will notify you of our decision. If your concept is preliminarily accepted, Jazz will invite you to submit a full protocol within 90 days of the notification.
Please be prepared to provide the following information at the time of your concept submission:
- Primary Investigator information and a current CV
- Study hypothesis, objectives, and endpoints
- Background & rationale
- Study design
- Subject population
- Statistical analysis plan
- Publication plan
- Preliminary budget (a detailed budget will be required at the protocol stage)
- Quantity of product requested (if applicable)
PIRA™ proposals are AI generated and are not reviewed or endorsed by the sponsoring company.