We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01048255
Recruitment Status : Completed
First Posted : January 13, 2010
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated

Tracking Information
First Submitted Date  ICMJE January 8, 2010
First Posted Date  ICMJE January 13, 2010
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE January 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) [ Time Frame: 18 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2010)
  • Percent reduction in seizure frequency [ Time Frame: 6 weeks ]
  • Percent of subjects with 50% or greater reduction in seizure frequency [ Time Frame: 6 weeks ]
  • Percent of subjects that become seizure free [ Time Frame: 2 weeks ]
  • Percent of subjects who discontinue study drug treatment [ Time Frame: 6 weeks ]
  • Plasma levels of study drug and other concomitant antiepileptic drugs [ Time Frame: 13 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
Official Title  ICMJE A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Partial Epilepsy
Intervention  ICMJE Drug: VX-765
300mg Oral Tablet, 900mg TID
Study Arms  ICMJE Experimental: VX-765
Intervention: Drug: VX-765
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2013)
60
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2010)
75
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01048255
Other Study ID Numbers  ICMJE VX09-765-401
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vertex Pharmaceuticals Incorporated
Original Responsible Party Chris Wright, MD, PhD, Vertex Pharmacuticals Incorporated
Current Study Sponsor  ICMJE Vertex Pharmaceuticals Incorporated
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chris Wright, MD, PhD Vertex Pharmaceuticals Incorporated
PRS Account Vertex Pharmaceuticals Incorporated
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP