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

Partial Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01048255
• Other study ID #: VX09-765-401
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2010
• Last updated: December 19, 2013
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2013
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsies, Partial
• Epilepsy
• Partial Epilepsy

Intervention

Drug:
• VX-765
300mg Oral Tablet, 900mg TID

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)		18 weeks	Yes
Secondary	Percent reduction in seizure frequency		6 weeks	No
Secondary	Percent of subjects with 50% or greater reduction in seizure frequency		6 weeks	No
Secondary	Percent of subjects that become seizure free		2 weeks	No
Secondary	Percent of subjects who discontinue study drug treatment		6 weeks	No
Secondary	Plasma levels of study drug and other concomitant antiepileptic drugs		13 weeks	No