Clinical trial NCT01048255: Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
Official title: A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Partial Epilepsy
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2010-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
timeFrame: 18 weeks
Secondary outcomes:
measure: Percent reduction in seizure frequency
timeFrame: 6 weeks
measure: Percent of subjects with 50% or greater reduction in seizure frequency
timeFrame: 6 weeks
measure: Percent of subjects that become seizure free
timeFrame: 2 weeks
measure: Percent of subjects who discontinue study drug treatment
timeFrame: 6 weeks
measure: Plasma levels of study drug and other concomitant antiepileptic drugs
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas
state: Arkansas
city: Newport Beach
country: United States
facility: California
state: California
city: Miami
country: United States
facility: Florida
state: Florida
city: Sarasota
country: United States
facility: Florida
state: Florida
city: Chicago
country: United States
facility: Illinois
state: Illinois
city: Baltimore
country: United States
facility: Maryland
state: Maryland
city: Bethesda
country: United States
facility: Maryland
state: Maryland
city: Chesterfield
country: United States
facility: Missouri
state: Missouri
city: Hackensack
country: United States
facility: New Jersey
state: New Jersey
city: New York
country: United States
facility: New York
state: New York
city: Philidelphia
country: United States
facility: Pennsylvania
state: Pennsylvania
city: Charlottesville
country: United States
facility: Virginia
state: Virginia
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Chris Wright, MD, PhD
role: STUDY_DIRECTOR
References: