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

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

Official Title
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A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy

Conditions
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Partial Epilepsy

Intervention / Treatment
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* Drug: VX-765


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VX-765<br> | Drug: VX-765<br>* 300mg Oral Tablet, 900mg TID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) |  | 18 weeks | 

Secondary Outcome Measures

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