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

• ClinicalTrials.gov Identifier: NCT01048255
• Recruitment Status: Completed
• First Posted: January 13, 2010
• Last Update Posted: January 27, 2014
• Sponsor: Vertex Pharmaceuticals Incorporated
• Information provided by (Responsible Party): Vertex Pharmaceuticals Incorporated

Study Description

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

Condition or disease	Intervention/treatment	Phase
Partial Epilepsy	Drug: VX-765	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: January 2010
• Actual Primary Completion Date: November 2010
• Actual Study Completion Date: November 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) [ Time Frame: 18 weeks ]

Secondary Outcome Measures :

1. Percent reduction in seizure frequency [ Time Frame: 6 weeks ]
2. Percent of subjects with 50% or greater reduction in seizure frequency [ Time Frame: 6 weeks ]
3. Percent of subjects that become seizure free [ Time Frame: 2 weeks ]
4. Percent of subjects who discontinue study drug treatment [ Time Frame: 6 weeks ]
5. Plasma levels of study drug and other concomitant antiepileptic drugs [ Time Frame: 13 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Vertex Pharmaceuticals Incorporated
• ClinicalTrials.gov Identifier: NCT01048255
• Other Study ID Numbers: VX09-765-401
• First Posted: January 13, 2010
• Last Update Posted: January 27, 2014
• Last Verified: December 2013

Additional relevant MeSH terms:

Epilepsy; Epilepsies, Partial; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases