NCT01048255CompletedPhase 2
A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
Vertex Pharmaceuticals Incorporated10 sites in 1 country60 target enrollmentStarted: January 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 60
- Locations
- 10
- Primary Endpoint
- Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
VX-765
Experimental
Intervention: VX-765 (Drug)
Outcomes
Primary Outcomes
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
Time Frame: 18 weeks
Secondary Outcomes
- Percent of subjects that become seizure free(2 weeks)
- Percent of subjects who discontinue study drug treatment(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)
- Percent reduction in seizure frequency(6 weeks)
Investigators
Study Sites (10)
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