Effective October 2020, the Insomnia Investigator Studies Program (MISP) Committee will accept proposals within our current areas of interest (AOI) up to March 4, 2021 for the first review cycle, up to July 8, 2022 for the second review cycle, and up to October 7, 2021 for the third review cycle. This is a competitive process that will be conducted by the Insomnia MISP in 2021. 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 program requests that investigators specify how they will support diversity in enrollment to include traditionally underrepresented minorities/ethnic groups.
The following areas are of interest to the Investigator Studies Program Committee:
- Human studies that differentiate the orexin receptor (OX1R and OX2R) antagonism mechanism of action from other hypnotics, e.g., through the use of novel sleep/wake metrics or other clinical or functional outcomes.
- Studies investigating the optimal diagnosis and treatment of insomnia, treatment patterns, care pathways and biomarker changes associated with the use of an orexin receptor antagonist in subpopulations 1 and clinical settings 2 ,especially in diseases or situations with a high prevalence of insomnia, or a high impact of its treatment.
- Studies investigating real-world function and costs in subpopulations1, including diseases or situations with a high prevalence of insomnia, and a high impact of insomnia treatment on health outcomes. In particular, caregiver burden in the treatment of Alzheimer’s Disease (AD) insomnia.
- Studies relevant to suvorexant that characterize insomnia by novel digital technologies including mobile devices, wearables, and remote sensing devices. Data technology, apps, digital behavioral tools, PRO’s, questionnaires or other methods to assess day-time function, activities, treatment outcomes, or clinical trial endpoints relevant to suvorexant.
- Studies assessing the treatment of insomnia, preferably with suvorexant, using digital therapeutics or novel digital technologies to assess day-time function, activities, treatment outcomes, and clinical trial endpoints.
- Nonclinical studies investigating sleep mechanisms related to orexins and insomnia, with a focus on translational functional measures.
1 Alzheimer’s disease, adult ADHD, diabetes, circadian rhythm disorder, delirium, epilepsy, hypertension, major depressive disorder, multiple sclerosis, oncology, Parkinson’s disease, and shift work. Note, insomnia in substance abuse is limited to drug support only.
2outpatient, inpatient, long-term care
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 protocol with 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:
| Activity |
1stReview Cycle |
2ndReview Cycle |
3rdReview Cycle |
| Protocol Submission / Detailed Budget |
Mar 4, 2021 |
July 8, 2021 |
Oct 7, 2021 |
| Decision to Investigator |
Mar 29, 2021 |
July 29, 2021 |
Oct 28, 2021 |