Partial Epilepsy
Conditions
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
Interventions
DRUGVX-765
300mg Oral Tablet, 900mg TID
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) | 18 weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed