Making the Complex Seamless® in Epilepsy Clinical Development
There is a high unmet need for treatment options for epilepsy and related neurodevelopmental disorders. Epilepsy trials require a clinical research organization (CRO) partner with the specialized expertise to effectively address the unique challenges involved to streamline your clinical research.
As a full-service and therapeutically-focused CRO with a unique approach to clinical development, Medpace specializes in the design and conduct of the most complex and challenging global trials in neuroscience clinical research, including epilepsy in both pediatric and adult populations. Leverage Medpace’s broad neuroscience experience in the design and management of Phase I-IV programs to keep your trial on time and on budget.
The Medpace Advantage
Gain a competitive advantage for your epilepsy and seizure disorder program through our global footprint, cross-functional team of medical and regulatory experts, clinical trial management teams, and fully integrated services.
Epilepsy Clinical Research Capabilities
Partner with a global CRO with a cross-functional collaborative model to position your epilepsy clinical trial for success. The Medpace neuroscience team can support your clinical trials through:
Broad experience in generalized and focal epilepsy, status epilepticus, Dravet syndrome, Lennox-Gastaut syndrome, Angelman syndrome, Infantile spasms, and more
Long-term relationships with experienced sites, networks, and key opinion leaders (KOLs) worldwide, providing access to the best sites for your specific program
Established relationships with vendors that support both onsite and home-based EEG monitoring
Experience designing electronic seizure diaries from the ground up within Medpace’s ePRO system, including development of ad hoc reporting for monitoring of compliance, automated alerts for sites and patients, and supplemental CRFs for capture of additional clinician provided information
Patient education and training to support the collection of high-quality seizure diary data and Patient Reported Outcomes (PROs)
Placebo mitigation strategies to limit the potential for placebo response through site and participant education
Integrated services, including wholly-owned Central Laboratories, Bioanalytical Lab, Imaging and ECG Core Lab, and Phase I Unit, as well as a Clinical Trial Management System that ties all study data together in a single platform
Strategic Patient Recruitment & Retention
Partnering with a CRO experienced in recruiting and enrolling epilepsy patients and that has relationships with key investigative sites is crucial. Our multi-dimensional recruitment model enables us to implement innovative, comprehensive, and customized recruitment and retention strategies to effectively target members of specific patient populations.
Patients with epilepsy face obstacles in their daily lives and minimizing burden is a critical component in recruiting a committed group of patients into studies. Patients with treatment resistant epilepsy may not be able to drive, creating barriers to study participation. Medpace Patient Concierge Services (PCS) provides global travel support to patients and caregivers to minimize burden while enhancing patient engagement, study compliance and retention, and site relationships to help keep the study on track.
“The most critical data collected in epilepsy studies is the seizure diary. Medpace’s ePRO system TrialPACE is ideally suited for the capture and oversight of seizure diary information with benefits for both patients and site staff, and significant advantages compared to systems available from external vendors.”
To successfully collect PRO data, consistent patient education and engagement is essential. Ensuring patients understand how to properly report their seizure activity and answer questionnaires in a consistent manner is critical to the success of studies in epilepsy.
To improve the quality of data collection, Medpace has developed an ePRO/eDiary component directly within its ClinTrak® suite of systems. Medpace’s ePRO system has been used to collect Seizure Diary, Medication Adherence, and PRO data to support critical study endpoints in epilepsy.
Specialized Imaging and ECG Core Lab for Your Epilepsy Program
Medpace Imaging and ECG Core Lab has over a decade of experience in global neuroscience trial management. Supported by a team of scientists, clinicians, technologists, project managers and coordinators, our imaging core lab can successfully integrate standard and novel neuroimaging biomarkers into Phase I-III studies from concept through design and execution.
Through Medpace’s wholly-owned cardiovascular core lab, we provide ECG acquisition and analysis services utilizing industry standard devices and systems. As a fully-integrated service, this allows ECG results to be interpreted in the context of all the other data.
The complexities of clinical development for epilepsy and related neurodevelopmental disorders require a high-level of integration and efficiency. Medpace offers strategic medical, regulatory, and operational experts that are involved from project initiation to completion with a broad range of experience in designing and conducting clinical trials in generalized and focal epilepsy, status epilepticus, Dravet syndrome, Lennox-Gastaut syndrome, Angelman syndrome, and Infantile spasms.
Serving as therapeutic team leaders, our in-house neuroscience physicians apply years of drug development experience to each study, providing greater depth of expertise and the ability to tackle complex and challenging diseases. Our medical experts are embedded within the project, consulting with the Sponsor, project team, and the investigative sites, ensuring our operational strategy is firmly aligned with the Sponsor’s scientific and medical objectives. Additionally, an integrated team of experienced neuroscience advanced clinical practitioners enrich the team with added medical and clinical perspectives, while proving a patient-centric and site-centric perspective to proactively address protocol challenges.
“Despite the available epilepsy treatments on the market today, many patients continue to have seizures, significantly impacting their quality of life. I am proud to work at Medpace to accelerate the global development of novel treatments for these patient communities with significant unmet needs.”
“Being an epileptologist and taking care of patients with intractable epilepsy for many years, I understand the significant disease burden and negative impact epilepsy has imposed to their lives. It is my passion to find optimal treatment for these patients. Being part of the Medpace team allows me to accelerate the development of safe and effective medical therapeutics for these patients that I deeply care for.”
