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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01048255
First received: January 8, 2010
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Partial Epilepsy
Drug: VX-765
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy

Resource links provided by NLM:


Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:
  • Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent reduction in seizure frequency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects with 50% or greater reduction in seizure frequency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects that become seizure free [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Percent of subjects who discontinue study drug treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Plasma levels of study drug and other concomitant antiepileptic drugs [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VX-765 Drug: VX-765
300mg Oral Tablet, 900mg TID

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048255

Locations
United States, Arkansas
Arkansas
Little Rock, Arkansas, United States
United States, California
California
Newport Beach, California, United States
United States, Florida
Florida
Miami, Florida, United States
Florida
Sarasota, Florida, United States
United States, Illinois
Illinois
Chicago, Illinois, United States
United States, Maryland
Maryland
Baltimore, Maryland, United States
Maryland
Bethesda, Maryland, United States
United States, Missouri
Missouri
Chesterfield, Missouri, United States
United States, New Jersey
New Jersey
Hackensack, New Jersey, United States
United States, New York
New York
New York, New York, United States
United States, Pennsylvania
Pennsylvania
Philidelphia, Pennsylvania, United States
United States, Virginia
Virginia
Charlottesville, Virginia, United States
Sponsors and Collaborators
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Chris Wright, MD, PhD Vertex Pharmaceuticals Incorporated
  More Information

No publications provided

Responsible Party: Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier: NCT01048255     History of Changes
Other Study ID Numbers: VX09-765-401
Study First Received: January 8, 2010
Last Updated: December 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 15, 2014