Phase
Condition
N/ATreatment
20mg/day PRAX-628 for 6 weeks then 30mg/day PRAX-628 for remaining 6 weeks
Placebo
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A diagnosis of focal onset epilepsy according to the International League AgainstEpilepsy (ILAE) Classification of Epilepsy.
Past evidence by computed tomography (CT) or magnetic resonance imaging (MRI) thathas ruled out a progressive cause of epilepsy in the judgement of the investigatorand/or in consultation with the medical monitor.
Exclusion
Exclusion Criteria:
Subject has had any of the of the following within the 12-month period precedingtrial entry: History of pseudo or psychogenic seizures, cluster seizures where theindividual seizures cannot be counted, an episode of convulsive status epilepticusrequiring hospitalization and intubation, or subject only has focal seizures withawareness that do not have motor activity.
Planned epilepsy surgery during the course of the clinical trial.
History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2years prior to enrollment or vagus nerve stimulation (VNS) implantation.
History of schizophrenia, obsessive-compulsive disorder, or other serious mentalhealth disorders.
History of malignancy, myeloproliferative or lymphoproliferative disorders withinthe past 5 years are excluded.
History of cardiac disease(s)/cardiac conduction disorders/or cardiac structuralabnormality(ies).
Has a positive test result or a known history of a positive test result for humanimmunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or anti-hepatitisC virus (HCV) antibody at Screening.
Is pregnant or is breastfeeding at the time of Screening or has a positive serumpregnancy test at Screening or is planning to become pregnant during the clinicaltrial or within 14 days of the last study drug dose.
Has received any other experimental or investigational drug, device or other therapywithin 30 days or 5 half-lives (whichever is longer) prior to Screening, or anyprior use of gene therapy.
Study Design
Study Description
Connect with a study center
Praxis Research Site
Barcelona, 08035
SpainActive - Recruiting
Praxis Research Site
Granda, 18012
SpainActive - Recruiting
Praxis Research Site
Madrid, 28040
SpainActive - Recruiting
Praxis Research Site
Málaga, 29010
SpainActive - Recruiting
Praxis Research Site
Terrassa, 08222
SpainActive - Recruiting
Praxis Research Site
Valencia, 46026
SpainActive - Recruiting
Praxis Research Site
Phoenix, Arizona 85032
United StatesActive - Recruiting
Praxis Research Site
DeLand, Florida 32720
United StatesActive - Recruiting
Praxis Research Site
Miami Lakes, Florida 33016
United StatesActive - Recruiting
Praxis Research Site
Chicago, Illinois 60640
United StatesActive - Recruiting
Praxis Research Site
Lafayette, Louisiana 70508
United StatesActive - Recruiting
Praxis Research Site
Bethesda, Maryland 20817
United StatesActive - Recruiting
Praxis Research Site
Chesterfield, Missouri 63005
United StatesActive - Recruiting
Praxis Research Site
Ozark, Missouri 65721
United StatesActive - Recruiting
Praxis Research Site
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Praxis Research Site
Middletown, New York 10940
United StatesActive - Recruiting
Praxis Research Site
Canton, Ohio 44718
United StatesActive - Recruiting
Praxis Research Site
Oklahoma City, Oklahoma 73112
United StatesActive - Recruiting
Praxis Research Site
El Paso, Texas 79912
United StatesActive - Recruiting
Praxis Research Site
Frisco, Texas 75034
United StatesActive - Recruiting
Praxis Research Site
Round Rock, Texas 78681
United StatesActive - Recruiting
Praxis Research Site
Seabrook, Texas 77586
United StatesActive - Recruiting

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