EpilepsyPhase 2NCT00567424
GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
A Phase 2 study testing GW273225 in people with Epilepsy, run by GlaxoSmithKline at 30 sites in United States.
Trial summary
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- GW273225
- How many people
- 0 participants
- Where
- 30 sitesUnited States
- Study dates
- Jul 2006to Mar 2008
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confident diagnosis of epilepsy
- Currently on VPA, CBZ or PHT
- >or= 4 seizures/4 weeks prior to screen
Who cannot join
- Prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)).
- Females of childbearing potential on hormonal contraceptives or hormone replacement therapy.
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
United States30 sites
GSK Clinical Trials Call Center
Amherst, New York, 14226
GSK Clinical Trials Call Center
Baltimore, Maryland, 21287
GSK Clinical Trials Call Center
Boston, Massachusetts, 02215
GSK Clinical Trials Call Center
Burlington, Vermont, 05401
GSK Clinical Trials Call Center
Chicago, Illinois, 60612
GSK Clinical Trials Call Center
Cleveland, Ohio, 44195
GSK Clinical Trials Call Center
Dallas, Texas, 75230
GSK Clinical Trials Call Center
Durham, North Carolina, 27560
GSK Clinical Trials Call Center
Iowa City, Iowa, 52242
GSK Clinical Trials Call Center
Jacksonville, Florida, 32209
GSK Clinical Trials Call Center
Little Rock, Arkansas, 72205
GSK Clinical Trials Call Center
Medford, Oregon, 97504
GSK Clinical Trials Call Center
Phoenix, Arizona, 85054
GSK Clinical Trials Call Center
Portland, Oregon, 97225
GSK Clinical Trials Call Center
Portland, Oregon, 97239-3098
GSK Clinical Trials Call Center
Richmond, Virginia, 23219
GSK Clinical Trials Call Center
Roanoke, Virginia, 24018
GSK Clinical Trials Call Center
Rochester, Minnesota, 55905
GSK Clinical Trials Call Center
Saint Cloud, Minnesota, 56303
GSK Clinical Trials Call Center
San Jose, California, 95128
GSK Clinical Trials Call Center
Santa Monica, California, 90404
GSK Clinical Trials Call Center
Seattle, Washington, 98104
GSK Clinical Trials Call Center
Springfield, Illinois, 62704
GSK Clinical Trials Call Center
Springfield, Missouri, 65804
GSK Clinical Trials Call Center
St Louis, Missouri, 63310
GSK Clinical Trials Call Center
Sun City, Arizona, 85351
GSK Clinical Trials Call Center
Tallahassee, Florida, 32308
GSK Clinical Trials Call Center
Tampa, Florida, 33613
GSK Clinical Trials Call Center
Toledo, Ohio, 43614
GSK Clinical Trials Call Center
Wichita, Kansas, 67214
About this study
Official title: An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin
- Conditions
- Epilepsy
- Being tested
- GW273225
- Keywords
- epilepsy, refractory, seizure, drug interactions, pharmacokinetics
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW273225Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).
Secondary outcomes (1)
Safety/tolerability of GW273225 in adults with refractory epilepsy Efficacy of GW273225 in adults with refractory epilepsy Potential initial starting doses for a subsequent placebo-controlled dose-ranging Phase IIb study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startJul 2006
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: No longer viable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00567424
- Sponsor's protocol ID
- NEC107055
- Status last verified
- Apr 2013
- First submitted
- 20 Jul 2006
- Last updated
- 4 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized
- ClinicalTrials.gov ID
- NCT00567424
- Acronym / sponsor ID
- NEC107055
- Conditions
- Epilepsy
- Keywords
- epilepsy, refractory, seizure, drug interactions, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer viable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 5 Dec 2007 (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.
Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confident diagnosis of epilepsy
- Currently on VPA, CBZ or PHT
- >or= 4 seizures/4 weeks prior to screen
Key exclusion criteria (2 listed)
- Prior lamotrigine use (excluded if treatment discontinued for clinically significant safety reasons (i.e., rash, hypersensitivity)).
- Females of childbearing potential on hormonal contraceptives or hormone replacement therapy.
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 |
|---|---|---|
| GW273225 | Drug | – |
Primary outcome
Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).
1 secondary outcome
Safety/tolerability of GW273225 in adults with refractory epilepsy Efficacy of GW273225 in adults with refractory epilepsy Potential initial starting doses for a subsequent placebo-controlled dose-ranging Phase IIb study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
Related trials for Epilepsy
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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.
GSK Clinical Trials, MD study director
GlaxoSmithKline
30 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 GW273225 in people with Epilepsy, run by GlaxoSmithKline at 30 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 was withdrawn before enrolling participants, so there are no results.
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?
Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2013.