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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 April 2013 |
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Main ID: |
NCT00567424 |
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Date of registration:
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20/07/2006 |
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Primary sponsor: |
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Public title:
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GW273225 Therapy Added To Current Seizure Treatments In Patients With Partial Seizures
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Scientific title:
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An Open-label Evaluation of Drug Interactions, Safety, Tolerability and Efficacy of GW273225 Add-on Treatment of Partial Seizures, Whether or Not Secondarily Generalized |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT00567424 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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GSK Clinical Trials, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Epilepsy
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Intervention(s)
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Drug: GW273225
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Primary Outcome(s)
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Pharmacokinetic drug interactions with the most common inhibiting and inducing antiepileptic drugs AEDs: valproate(VPA), carbamazepine(CBZ) and phenytoin (PHT).
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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NEC107055
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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