Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy

Phase 2

Completed

Brief Summary: The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in subjects with Treatment-resistant Partial Epilepsy

Recruitment & Eligibility

Inclusion Criteria

Subjects that are male or female aged 18 to 64 years (inclusive) with a body mass index between 18 and 35 (kg/m2)
Subjects must have a diagnosis and history of treatment resistant partial onset seizures for which they are taking 1 to 4 concomitant antiepileptic drugs (AED). Treatment resistance is defined as failure to achieve seizure freedom despite adequate use of 2 different AEDs. All AED doses must remain stable for 4 weeks prior to the Screening Visit and throughout the entire study
Subjects must have had at least 1 electroencephalogram (EEG) consistent with partial epilepsy and a brain magnetic resource imaging (MRI) or computed tomography (CT) scan within 5 years of Screening Visit negative for other confounding conditions
Subjects must have had at least 6 observable partial seizures in 6 weeks prior to randomization, with at least 1 seizure per week during 3 of the 6 weeks within the Baseline Period
Subjects who are male or female must agree to use acceptable contraceptive methods as defined in the protocol
Subjects who are in otherwise good health

Exclusion Criteria

Subjects with a history of non-epileptic transient alterations in consciousness
Subjects who have a history of status epilepticus in the past 12 months
Subjects whose seizure frequency cannot be quantified
Subjects who have significant medical illness including kidney, liver, pulmonary or gastrointestinal disease; or unstable or poorly controlled conditions
Subjects who have clinically significant psychiatric illness
Subjects with a positive drug screen (excluding any allowed prescribed medications) and history of alcoholism or drug addiction within past 2 years
Males subjects that have a female partner of childbearing potential who do not agree to use medically approved methods of birth control
Male subjects that have a female partner who is pregnant, nursing, or is planning to become pregnant during the study period, or within 90 days of the last dose of study drug
Female subjects who are pregnant or lactating, or who are of reproductive potential who do not agree to use medically approved birth-control methods
Subjects with a current or prior history of illness precluding them from immunomodulatory therapy (e.g. history of recurrent infections)
Subjects with active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Subjects who have participated in any other clinical trials involving an investigational product or device and have received the last dose of study drug within 45 days or 5 half-lives of the Screening Visit

Arm && Interventions

Group	Intervention	Description
VX-765	VX-765	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)	18 weeks

Secondary Outcome Measures

Name	Time	Method
Percent of subjects who discontinue study drug treatment	6 weeks
Percent of subjects that become seizure free	2 weeks
Percent reduction in seizure frequency	6 weeks
Percent of subjects with 50% or greater reduction in seizure frequency	6 weeks
Plasma levels of study drug and other concomitant antiepileptic drugs	13 weeks

Locations (10): Florida
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Sarasota, Florida, United States
New York
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New York, New York, United States
Missouri
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Chesterfield, Missouri, United States
Virginia
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Charlottesville, Virginia, United States
New Jersey
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Hackensack, New Jersey, United States
Pennsylvania
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Philidelphia, Pennsylvania, United States
Arkansas
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Little Rock, Arkansas, United States
Maryland
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Bethesda, Maryland, United States
California
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Newport Beach, California, United States
Illinois
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Chicago, Illinois, United States