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Epilepsy Outcomes

Epilepsy Outcomes Research

Patient-centered epilepsy research at Yale has led to major advances in the diagnosis and treatment of epilepsy. Yale was one of the first centers in the world to perform epilepsy neurosurgery and remains at the forefront in developing innovative brain imaging methods, deep brain stimulation, other neurosurgical techniques, medication trials, and additional novel approaches. 

The Altalib Lab performs clinical trials and cohort studies in collaboration with pharmaceutical companies, academic institutions, VA Healthcare Connecticut, and the Department of Defense, among other organizations. In addition to advancing epilepsy outcomes research, the Altalib Lab provides exposure and experience with mixed methodology, biostatistical data analysis, clinical trial management systems, electronic data capture and career mentorship. 

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Current Projects

Human Epilepsy Project - 3:                             Currently Enrolling!

The Human Epilepsy Project (HEP-3) is a multi-center, prospective cohort study of participants with generalized epilepsy. The study hopes to clarify the likelihood of response and remission in this type of epilepsy, as well as to explore the underlying biological drivers of treatment response, including the impact of microbiome and genetics. By enrolling both newly diagnosed participants (prognosis unknown) as well as participants with established primary generalized epilepsy who are already determined to be treatment resistant or treatment responsive, we can immediately test potential biomarkers in a confirmation cohort. This will accelerate identification of predictive bio-markers and allow those with epilepsy to make more informed decisions about the factors affecting their quality of life. Participation is compensated.

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HEP-3 Inclusion/ Exclusion Criteria
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REALIZE (CVL - 865) Study:                                   Currently Enrolling! 

The REALIZE study is a multicenter, randomized, placebo-controlled parallel group trial of CVL - 865 for an adjunctive treatment of focal onset epilepsy. CVL - 865 is an investigational drug reported to be a non-sedating benzodiazepine. The study will examine CVL - 865's effectiveness in decreasing the number of focal onset seizures, also known as partial seizures, without causing too many side effects. Patients aged 18 - 75 years old with focal seizures for at least two years and a failure of two or more anti-seizure medications are eligible to participate in this study. (The complete list of study requirements for this study can be accessed from Dr. Hamada Altalib, the study doctor.) The study spans a maximum of 25 weeks, including an 8-week screening period, a 10- or 13- week treatment period, and a 4-week follow-up period. 

Cerevel 865 Inclusion Exclusion Criteria
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Brivaracetam (BRV) EPI008 Study:

BRV EP008 is a multicenter, noninterventional, observational study to evaluate real-world outcomes in people with focal onset epilepsy.  The goal of the study is to determine the efficacy and tolerability of BRV, including psychiatric and quality of life outcomes in the clinical setting. In collaboration with the Epilepsy Consortium (PI: Jacqueline A. French, M.D.), preliminary analysis has shown that BRV treatment substantially improved patient anger/anxiety/depression/fatigue/sleep disturbance/disability within the first 1.5 months (maintained for 12 months among patients remaining on BRV). BRV improved overall disability, disability due to seizures and side effects according to Seizure-Related Disability Assessment Scale (SERDAS).

Enrollment closed.

Effectiveness & Tolerability of Brivaracetam by Reason for Initiation in Adults with Focal Seizures

Effectiveness and Tolerability of Brivaracetam by Reason for Initiation in Adults with Focal Seizures: Post-hoc Analysis of a Real-world, US Study (P15-8.003)

Epidemiology of Epilepsy and Traumatic Brain Injury - Severity, Mechanism, and Outcomes:

This study utilizes data from existing VA and Department of Defense data repositories, patient self-reports from surveys/ interviews and data collected through the Chronic Effects of Neurotrauma Consortium (CENC) longitudinal cohort study. Altalib Lab collaborated the Foundation for Advancing Veterans Health Research (PI: Mary Jo Pugh PhD) to examine population prevalence of epilepsy, identify its association of mTBI, assess outcomes associated with epilepsy, identify neuroimaging and biomarker correlates of mTBI and epilepsy, and reveal neuroimaging and biomarker correlates of mTBI and epilepsy. An initial emergent theme has indicated intimate partner violence as a contributing factor to cases of TBI. 

Enrollment closed.

Figure 3 QOLIE-10 Item Breakout Across Epilepsy Subgroups The 4 group means for each of the 10 individual items of the Quality of Life in Epilepsy Inventory (QOLIE-10) are shown along each line. Higher percentages indicate high limitations, and 100% indicates the maximum reportable score for each item. CIs are intentionally excluded to enhance visualization. Caution is advised in drawing conclusions from single item differences across groups. ASM = antiseizure medication; DRE = drug-resistant epilepsy; PTE = posttraumatic epilepsy; PT-DRE = posttraumatic DRE.

QOLIE-10 Item Breakout Across Epilepsy Subgroups The 4 group means for each of the 10 individual items of the Quality of Life in Epilepsy Inventory (QOLIE-10) are shown along each line. Higher percentages indicate high limitations, and 100% indicates the maximum reportable score for each item. CIs are intentionally excluded to enhance visualization. Caution is advised in drawing conclusions from single item differences across groups. ASM = antiseizure medication; DRE = drug-resistant epilepsy; PTE = posttraumatic epilepsy; PT-DRE = posttraumatic DRE.

Past Projects

ENGAGE Trial:

Multicenter, Phase II randomized control trial evaluating the efficacy of staccato alprazolam as a rescue treatment for people with cluster seizures. 

Human Epilepsy Project 1 & 2:

Multi-center cohort study that characterizes the risk factors, biomarkers, response to treatment, and natural course of illness of newly diagnosed focal onset epilepsy (HEP 1) and medication refractory focal onset epilepsy (HEP 2).

Pfizer Lyrica A0081096:

Multicenter prospective, placebo controlled, randomized clinical trial to evaluate the effect of pregabalin on vision function.

Collaborations

Epilepsy Outcomes Network
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