Clinical Research Directory

A Study Evaluating NPT 2042 Versus Placebo in Subjects Aged 16-75 Years With Genetic Generalized Epilepsy (GGE) and Absence Seizures

This study will compare the effect of NPT 2042 and placebo in subjects with GGE on the frequency and duration of electroencephalographic absence seizures, separated by a 14-day washout period. The study will be a single-center, double-blind, crossover study with subjects receiving either NPT 2042 BID orally or matching placebo BID in each of two treatment periods. Two doses of NPT 2042 will be evaluated.

The Effect of Mandala Coloring on the Quality of Life in Epilepsy Patients: A Single Blind Randomized Controlled Study

Epilepsy is among the most prevalent and serious neurological disorders. While antiepileptic medications play a crucial role in managing the condition, additional support through counseling, education, cognitive behavioral therapy, and social assistance for both patients and their families is essential. Furthermore, incorporating art-based interventions is vital due to their beneficial effects on life quality and their significance in health promotion and prevention. Research suggests that art therapy can aid patients in managing their symptoms and enhancing their overall well-being. Currently, mandalas are being effectively utilized in art therapy practices. However, a review of the literature reveals a lack of studies examining the impact of mandala art therapy on the quality of life for individuals with epilepsy. This randomized controlled trial aims to assess how mandala painting influences the quality of life in epilepsy patients. The study will involve adult epilepsy patients from Gümüşhane State Hospital Neurology Polyclinic. Participants will be randomly assigned to either a control group or an experimental group using a lottery method, known as "Full (Simple) Randomization." Data will be gathered through a patient information form and the "Quality of Life Scale in Epilepsy (QOLIE-31)." The experimental group will receive materials for mandala painting and will be instructed to complete one mandala at home three times a week over the course of twenty-four sessions (two months), with each session lasting approximately 30 minutes. All participants will undergo the "Patient Information Form" and "QQLI-31" assessment prior to the study (pre-test), with the "QQLI-31" reassessed in the 4th week (intermediate measurement) and again in the 8th week (post-test). The results will be analyzed to determine the impact of mandala therapy on the quality of life in epilepsy patients.

Baker Gordon Syndrome Natural History Study

The goal of this study is to conduct a prospective, longitudinal assessment of the natural clinical progression of children and adults with Synaptotagmin1-Associated Neurodevelopmental Disorder also known as Baker Gordon Syndrome (BAGOS). This will be performed by acquiring baseline measurements and developing effective outcome measures and diagnostic tools for the disorder, to prepare the healthcare system for future clinical trials.

ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

To investigate the efficacy and safety of ONO-2017 in combination with antiepileptics in Japanese epileptic patients with generalized tonic-clonic seizures.