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

A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy

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

Study Overview

• Status: Completed
• Conditions: Partial Epilepsy
• Intervention / Treatment: Drug: VX-765

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States
      • Arkansas
  • California
    • Newport Beach, California, United States
      • California
  • Florida
    • Miami, Florida, United States
      • Florida
    • Sarasota, Florida, United States
      • Florida
  • Illinois
    • Chicago, Illinois, United States
      • Illinois
  • Maryland
    • Baltimore, Maryland, United States
      • Maryland
    • Bethesda, Maryland, United States
      • Maryland
  • Missouri
    • Chesterfield, Missouri, United States
      • Missouri
  • New Jersey
    • Hackensack, New Jersey, United States
      • New Jersey
  • New York
    • New York, New York, United States
      • New York
  • Pennsylvania
    • Philidelphia, Pennsylvania, United States
      • Pennsylvania
  • Virginia
    • Charlottesville, Virginia, United States
      • Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VX-765	Drug: VX-765; 300mg Oral Tablet, 900mg TID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)	18 weeks

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Vertex Pharmaceuticals Incorporated
• Investigators: Study Director: Chris Wright, MD, PhD, Vertex Pharmaceuticals Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: January 8, 2010
• First Submitted That Met QC Criteria: January 11, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): January 27, 2014
• Last Update Submitted That Met QC Criteria: December 19, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsies, Partial
• Other Study ID Numbers: VX09-765-401