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

NCT01048255 | Completed Phase 2

• 1 other identifier: VX09-765-401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 12

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

Conditions

Partial Epilepsy

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)

  18 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

VX-765

EXPERIMENTAL

Drug: VX-765

Interventions

VX-765 DRUG

300mg Oral Tablet, 900mg TID

VX-765

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (12)

Arkansas

Little Rock, Arkansas, United States

Location

California

Newport Beach, California, United States

Location

Florida

Miami, Florida, United States

Location

Florida

Sarasota, Florida, United States

Location

Illinois

Chicago, Illinois, United States

Location

Maryland

Baltimore, Maryland, United States

Location

Maryland

Bethesda, Maryland, United States

Location

Missouri

Chesterfield, Missouri, United States

Location

New Jersey

Hackensack, New Jersey, United States

Location

New York

New York, New York, United States

Location

Pennsylvania

Philidelphia, Pennsylvania, United States

Location

Virginia

Charlottesville, Virginia, United States

Location

Related Publications (1)

• 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.

  PMID: 37842826 DERIVED

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

belnacasan

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Chris Wright, MD, PhD

  Vertex Pharmaceuticals Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 13, 2010
• Study Start: January 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 27, 2014

Record last verified: 2013-12

Locations

US (12)