Investigator Initiated Studies
Marinus is committed to advancing research to inform the optimal clinical use of ganaxolone, complement Marinus preclinical and clinical research, and explore opportunities to further address unmet medical needs. Supporting unsolicited external independent research, referred to as Investigator Initiated Studies (IIS), is one way in which Marinus demonstrates this commitment.
Marinus supports unsolicited IIS proposals with consideration to scientific merit, patient safety, research ethics, alignment with our research interests, as well as legal and budgetary criteria.
This program is open to qualified investigators with the experience, training and facilities to conduct independent research.
Research Areas of Interest
Marinus is interested in receiving proposals for research that are within our current areas of interest. These include further defining the appropriate clinical use of ganaxolone in CDKL5 deficiency disorder, studies in developmental and epileptic encephalopathies (DEEs) and other refractory epilepsies, and research that provides preclinical or clinical proof-of-concept data to inform future clinical development. For these types of epilepsy syndromes, we are interested in the following:
- Basic and Translational Research Proposals
- Research related to the identification of potential treatment targets or roles for the use of ganaxolone
- Research related to the identification of disease mechanisms
- Clinical Research Proposals
- Research that further informs the appropriate clinical use of ganaxolone in CDD
- Research which seeks to provide proof of concept for the therapeutic role of ganaxolone
- Epidemiology/Observational Research Proposals
- Research with a focus on unmet medical needs, cost of care, caregiver and patient burden of illness, and quality of life
IIS Submission and Review Process
Submission Process
Submissions are accepted on a continuous basis. All requests must be submitted through the Marinus IIS form. You can elect to receive a copy of your submission by ticking the box labeled as such at the bottom of the form.
The form entries cannot be saved while in progress; it is advised to have all required information available when you are ready to complete the form and submit the request. Please see the IIS Initial Concept Proposal Worksheet to assist in preparing your information for submission through the form.
For any questions regarding your submission, please contact us at: ResearchGrants@marinuspharma.com.
Initial Concept Proposal Submission & Review
The initial concept proposal submission should consist of a brief summary of your proposal and estimated study budget for initial evaluation. A complete budget/protocol is not required or requested at this stage; the initial concept is intended to be a synopsis of the proposed study for initial evaluation purposes.
Applications are reviewed with consideration to scientific merit, patient safety, alignment with our research interests, as well as legal and budgetary criteria. Funding requests will be evaluated for conformity to fair market value. Review committee meetings are held regularly throughout the year.
Following review of the initial concept proposal, the investigator will be notified of the committee’s decision. If the initial concept is approved, the investigator will be contacted with details regarding the next steps, which includes submission of the full proposal, including the full protocol and complete study budget, for further evaluation. Approval of the initial concept and request for the full proposal does not imply or guarantee approval.