Last updated: 11/04/2018 09:39:14
GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
GSK study ID
NEC107055
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Withdrawn
Withdrawn
Trial overview
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
Trial description: Study to determine drug interactions between GW273225 and the anticonvulsants valproate, carbamazepine or phenytoin
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Drug: GW273225
Enrollment:
0
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Epilepsy
Product
GW273225
Collaborators
None
Study date(s)
March 2008 to January 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Confident diagnosis of epilepsy
- Currently on VPA, CBZ or PHT
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- Confident diagnosis of epilepsy
- Currently on VPA, CBZ or PHT
- >or= 4 seizures/4 weeks prior to screen
Exclusion criteria:
- 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 location(s)
Location
GSK Clinical Trials Call Center
Toledo, OH, United States, 43614
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Tallahassee, FL, United States, 32308
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
St. Cloud, MN, United States, 56303
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Little Rock, AR, United States, 72205
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Medford, OR, United States, 97504
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Rochester, MN, United States, 55905
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Portland, OR, United States, 97239-3098
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Phoenix, AZ, United States, 85054
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Cleveland, OH, United States, 44195
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Springfield, MO, United States, 65804
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Jacksonville, FL, United States, 32209
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Iowa City, IA, United States, 52242
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Baltimore, MD, United States, 21287
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Roanoke, VA, United States, 24018
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
San Jose, CA, United States, 95128
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
St. Louis, MO, United States, 63310
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Durham, NC, United States, 27560
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Chicago, IL, United States, 60612
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Boston, MA, United States, 02215
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Santa Monica, CA, United States, 90404
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Dallas, TX, United States, 75230
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Wichita, KS, United States, 67214
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Seattle, WA, United States, 98104
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Burlington, VT, United States, 05401
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Springfield, IL, United States, 62704
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Sun City, AZ, United States, 85351
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Tampa, FL, United States, 33613
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Richmond, VA, United States, 23219
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Portland, OR, United States, 97225
Status
Will Be Recruiting
Location
GSK Clinical Trials Call Center
Amherst, NY, United States, 14226
Status
Will Be Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Withdrawn
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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