Principal Investigators (PIs) in CNS drug development face unique challenges. These challenges are particularly significant when trying to establish the safety of drugs with known preclinical or theoretical seizure risks and the efficacy of drugs developed for epilepsy. Addressing these critical issues is essential for advancing CNS drug development and improving patient outcomes. Synthesys Brain Health offers advanced solutions to address these pain points using EEG technology.
Drugs with a potential seizure risk require precise and scientifically grounded monitoring. Synthesys Brain Health provides expert EEG consulting services that enable principled trial design, protecting human subjects while minimizing trial risk. By incorporating real-time, continuous tracking of brain activity, subclinical seizures or abnormal brain patterns that might otherwise go unnoticed can be detected. This proactive approach ensures higher levels of safety and compliance during clinical trials.
EEG technology offers a direct view of the effects of a drug on ictal and interictal activity, unlike traditional seizure diaries, which have been shown to underreport seizures by up to 50%. Synthesys Brain Health’s EEG services provide a systematic and efficient way to quantify these discharges, offering precise data that supports the evaluation of a drug’s efficacy.
Ensuring that drugs effectively cross the blood-brain barrier (BBB) is essential for establishing a clear relationship between drug dosing, changes in brain activity, and clinical outcomes. Synthesys Brain Health provides the expertise and tools necessary for thorough pharmacokinetic (PK) and pharmacodynamic (PD) analysis, helping researchers verify BBB penetration and its impact on CNS activity.
EEG biomarkers hold significant potential in predicting disease progression and treatment response. Synthesys Brain Health employs standardized and ambulatory EEG equipment, operated by qualified staff, for the collection and analysis of these biomarkers. By leveraging this data, researchers can uncover insights that advance the understanding of CNS disorders and improve therapeutic strategies.
Integrating EEG services into CNS clinical trials enhances safety, efficacy, and biomarker development, ultimately accelerating the development of effective treatments. Collaboration and innovation are key to overcoming the challenges faced in CNS drug development.
How are you using EEG or other advanced technologies in your clinical trials? Let’s work together to tackle these challenges and drive meaningful advancements in CNS drug development.
