Effective November 2019, the Insomnia Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 14, 2020 for the first review cycle, up to May 20, 2020 for the second review cycle, and up to September 28, 2020 for the third review cycle. This is a competitive process that will be conducted by the Insomnia MISP in 2020. 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 the orexin receptor (OX1R and OX2R) 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 diagnosis and treatment of insomnia, treatment patterns, and biomarker changes associated with the use of an orexin receptor antagonist in various subpopulations1 and clinical settings (e.g. outpatient, inpatient, long-term care).
- Application of preference health research (including but not limited to conjoint analysis, adaptive choice CA, Multi-choice decisional analysis, etc.) to the study of sleep disturbances and/or insomnia.
- Studies investigating real-world function and costs in subpopulations1 of interest, including caregiver burden in the treatment of Alzheimer’s Disease (AD) insomnia.
- Studies, preferably those using suvorexant, that assess the development, utility, and application of novel digital health technologies including, mobile devices, wearables, and other remote sensing device/data technology for diagnosing and characterizing insomnia, treatment outcomes, and future clinical trial endpoints.
- Nonclinical studies investigating sleep promoting mechanisms with a focus on translational functional measures related to insomnia.
1 Subpopulations of interest include those diseases or situations in which there is a high prevalence of and impact on health outcomes associated with the treatment of insomnia including but not limited to: Alzheimer’s disease, diabetes, circadian rhythm disorder, epilepsy, hypertension, major depressive disorder, multiple sclerosis, Parkinson’s disease, shift work, substance abuse, delirium.
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
||Mar 14, 2020
||May 20, 2020
||Sep 28, 2020
|Decision to Investigator
||Apr 10, 2020
||Jun 12, 2020
||Oct 18, 2020