Partial EpilepsyPhase 2NCT01048255
Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
A Phase 2 study testing VX-765 in people with Partial Epilepsy, run by Vertex Pharmaceuticals Incorporated at 12 sites in United States.
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 Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Partial Epilepsy
- What is being tested?
- VX-765
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesUnited States
- Study dates
- Jan 2010to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Maryland
Baltimore, Maryland
Maryland
Bethesda, Maryland
Virginia
Charlottesville, Virginia
Missouri
Chesterfield, Missouri
Illinois
Chicago, Illinois
New Jersey
Hackensack, New Jersey
Arkansas
Little Rock, Arkansas
Florida
Miami, Florida
New York
New York, New York
California
Newport Beach, California
Pennsylvania
Philidelphia, Pennsylvania
Florida
Sarasota, Florida
About this study
Official title: A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
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
- Being tested
- VX-765
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-765Drug
300mg Oral Tablet, 900mg TID
| Study group | Role | What they receive |
|---|---|---|
| VX-765 | Experimental | Not described Receives: Drug: VX-765 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
Measured: 18 weeks
Secondary outcomes (5)
Percent reduction in seizure frequency
Measured: 6 weeks
Percent of subjects with 50% or greater reduction in seizure frequency
Measured: 6 weeks
Percent of subjects that become seizure free
Measured: 2 weeks
Percent of subjects who discontinue study drug treatment
Measured: 6 weeks
Plasma levels of study drug and other concomitant antiepileptic drugs
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial EpilepsyStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chris Wright, MD, PhD, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01048255
- Sponsor's protocol ID
- VX09-765-401
- Status last verified
- Dec 2013
- First submitted
- 8 Jan 2010
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37842826
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-blind,Placebo-controlled Study of VX-765 in Subjects With Treatment-resistant Partial Epilepsy
- ClinicalTrials.gov ID
- NCT01048255
- Acronym / sponsor ID
- VX09-765-401
- Conditions
- Partial Epilepsy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety, tolerability, and efficacy of VX-765 in subjects with Treatment-resistant Partial Epilepsy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VX-765 | Experimental | Drug: VX-765 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VX-765300mg Oral Tablet, 900mg TID | Drug | VX-765 |
Primary outcome
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events)
Time frame: 18 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
- Derived from this study: PubMed 37842826Panebianco 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris Wright, MD, PhD study director
Vertex Pharmaceuticals Incorporated
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-765 in people with Partial Epilepsy, run by Vertex Pharmaceuticals Incorporated at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability (vital sign assessments, physical and neurological examinations, laboratory assessments, and adverse events) (time frame: 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01048255, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2014.