The WEPOD Study (Women with Epilepsy Pregnancy Outcomes and Deliveries), uses Irody’s ActivPrescription technology for detailed tracking of fertility and birth outcomes among women having epilepsy, compared to a healthy control group.
The WEPOD study is a multisite, three-year clinical study. This three-center prospective cohort study examines fertility patterns among women with epilepsy compared to an age-matched group of women without epilepsy.
The WEPOD clinical study provided study participants with Irody’s ActivPrescription technology on iPod Touch devices to record study-related information each day. The app also sends reminders to increase compliance.
WEPOD clinical investigators monitor and analyze participants’ daily activities in real-time, a significant advance over traditional clinical study methods.
The HEP Study (Human Epilepsy Project) is a large, prospective study whose primary objective is to identify clinical characteristics and biomarkers predictive of disease outcome and progression, and treatment response in patients with recently diagnosed focal epilepsy.
HEP collects high-resolution clinical information and treatment response, MRI’s, EEG, and blood and urine samples for biomarkers. A major outcome of the project is to create an open data repository of clinical information and biologic samples for future studies.
HEP is established as a partnership between 27 academic centers, foundations and industry. HEP will enroll 500 patients with newly or recently diagnosed focal epilepsy and will follow these patients for a minimum of three years and characterize their clinical course and evolution.
An iPod Touch device with Irody’s software is provided to each participant. A special interactive reminder system, controlled by the study coordinators was developed for this study. Irody’s back-end system is used for patient control and for data acquisition and management.
Irody is providing a customized mobile patient diary on the web and mobile devices – in English and Spanish, and a patient management and data management portal.
MONEAD is an epilepsy study related to maternal outcomes for women who received epilepsy medications while pregnant. This is a multicenter study designed to assess the safety of newer antiepileptic drugs used in pregnancy, both for the mother and the child.
In addition to assessing newer antiepileptic drugs, MONEAD will be assessing the safety of AED drugs not just for the child but also for the mother. Specifically, MONEAD will assess three major areas of outcome:
- Which drug causes the lowest incidence of malformations or other problems in children born to mothers with epilepsy receiving antiepileptic drugs.
- Does having epilepsy and/or taking antiepileptic drugs increase the risk of pregnancy complications such as ecclampsia (seizures in a pregnant woman not related to a pre-existing brain condition) or other problems?
- Does pregnancy cause worsening of the epilepsy in the mother?
A total of 21 sites and more than 500 patients are participating, including Columbia University, the University of Pittsburgh and the University of Southern California in addition to UC and Emory.
Irody is providing a set of patient-facing iPhone and web apps and a cloud-based patient and data management platform.
GCS (Georgia Cannabidoil Study) is supported by the state of Georgia, along with GW Pharmaceuticals, started in mid 2015. It’s aim is to evaluate GW’s investigational cannabidiol (CBD) product Epidiolex®, which has promising data for difficult to treat childhood epilepsies.
Georgia Governor Nathan Deal announced in April 2014 his support for clinical research that would investigate the use of CBD, a non-psychoactive component of the cannabis (marijuana) plant, and develop rigorous data that will inform and expand the scientific community’s understanding of potential treatments.
Irody is providing a full set of patient-facing iPhone, Android and web apps and a cloud-based patient and data management platform.
MCAMS (Mobile Comprehensive Assessments in Multiple Sclerosis) is conducted by Brigham and Women’s hospital (BWH) in Boston, funded by Biogen, to learn more about specific use of Biuogen’s Tecfidera. Irody is providing a full set of iPhone and Android apps and a cloud-based patient and data management platform.