Investigator Studies Program (MISP): Insomnia
Effective November 2018, the Insomnia Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 15, 2019 for the first review cycle and up to June 28, 2019 for the second review cycle. This is a competitive process that will be conducted by the Insomnia MISP in 2019. Decisions will be made based on scientific merit and strategic fit within the AOI. Please review the critical activities and abide by the timelines as outlined below.
The following areas are of interest to the Investigator Studies Program Committee:
- Human studies that characterize differentiating attributes of orexin receptor antagonism mechanism of action, e.g., through the use of novel sleep/wake metrics or other relevant clinical and functional outcomes.
- Studies investigating the optimal treatment of insomnia, treatment patterns, and real-world use of an orexin receptor antagonist in various clinical settings (e.g. outpatient, inpatient, long-term care) and in medical and neuropsychiatric subpopulations.
- Studies, preferably those using suvorexant, that assess the utility of validated mobile devices, wearables, and other remote sensing device/data technology for characterizing insomnia and treatment outcomes.
- Nonclinical studies investigating sleep promoting mechanisms with a focus on translational functional measures related to insomnia.
Note: BELSOMRA® has been designated by the US DEA as a Schedule IV Controlled Substance. US Investigator initiated study sites and site personnel must provide proof of Federal Registration and State Licensure. All study sites must have standard operating procedures in place for compliance with all applicable controlled substance laws and regulations
Please complete a full protocol and detailed budget via Visiontracker
, the Company's on-line study management system (in US) or your MSD country representative (outside US). The proposals will be collectively reviewed and selected by the Insomnia MISP Committee.
Critical Activities and Timelines:
|Full Protocol Submission / Detailed Budget
||March 15, 2019
||June 28, 2019
This site is intended for US investigators only. Investigators outside of the US interested in submitting research proposals to the Investigator
Studies Program should contact their local MSD office