Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
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| ClinicalTrials.gov Identifier: NCT01048255 |
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Recruitment Status :
Completed
First Posted : January 13, 2010
Last Update Posted : January 27, 2014
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Sponsor:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
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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 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 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Autosomal dominant partial epilepsy with auditory features
Pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Epilepsy
| Arm | Intervention/treatment |
|---|---|
| Experimental: VX-765 |
Drug: VX-765
300mg Oral Tablet, 900mg TID |
Primary Outcome Measures :
- Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) [ Time Frame: 18 weeks ]
Secondary Outcome Measures :
- 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 ]
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| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048255
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 |
| Responsible Party: | Vertex Pharmaceuticals Incorporated |
| ClinicalTrials.gov Identifier: | NCT01048255 History of Changes |
| Other Study ID Numbers: |
VX09-765-401 |
| First Posted: | January 13, 2010 Key Record Dates |
| Last Update Posted: | January 27, 2014 |
| Last Verified: | December 2013 |
Additional relevant MeSH terms:
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Epilepsy Epilepsies, Partial Brain Diseases Central Nervous System Diseases Nervous System Diseases |