Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
NCT ID: NCT01048255
Last Updated: 2014-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-01-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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VX-765
VX-765
300mg Oral Tablet, 900mg TID
Interventions
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VX-765
300mg Oral Tablet, 900mg TID
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
64 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Wright, MD, PhD
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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Arkansas
Little Rock, Arkansas, United States
California
Newport Beach, California, United States
Florida
Miami, Florida, United States
Florida
Sarasota, Florida, United States
Illinois
Chicago, Illinois, United States
Maryland
Baltimore, Maryland, United States
Maryland
Bethesda, Maryland, United States
Missouri
Chesterfield, Missouri, United States
New Jersey
Hackensack, New Jersey, United States
New York
New York, New York, United States
Pennsylvania
Philidelphia, Pennsylvania, United States
Virginia
Charlottesville, Virginia, United States
Countries
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References
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Panebianco M, Walker L, Marson AG. Immunomodulatory interventions for focal epilepsy. Cochrane Database Syst Rev. 2023 Oct 16;10(10):CD009945. doi: 10.1002/14651858.CD009945.pub3.
Other Identifiers
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VX09-765-401
Identifier Type: -
Identifier Source: org_study_id
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