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Anti-epileptic drug
DEPAKOTE 250mg for Epilepsy (Epilepsy Trial)
Phase 1
Waitlist Available
Led By Bradley D. Vince, DO
Research Sponsored by Vince & Associates Clinical Research, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2.5 months
Awards & highlights
Summary
A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2.5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Depakote
Trial Design
2Treatment groups
Active Control
Group I: DEPAKOTE 250mgActive Control2 Interventions
Treatment B: A single 2-tablet dose of DEPAKOTE ER tablet, 250mg. Each subject will have 2 treament period with this medication and 2 treatment periods with a single 2-tablet dose of Divalproex Sodium Extended-Release 250mg tablet.
Group II: Divalproex Sodium Extended Release 250mgActive Control2 Interventions
Treatment A: A single 2-tablet dose of divalproex sodium extended-release tablet, 250mg. Each subject will have 2 treatments with this medication and two treatments with a single 2-tablet dose of DEPAKOTE 250mg tablet.
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Who is running the clinical trial?
Vince & Associates Clinical Research, Inc.Lead Sponsor
5 Previous Clinical Trials
295 Total Patients Enrolled
Food and Drug Administration (FDA)FED
178 Previous Clinical Trials
1,543,575 Total Patients Enrolled
3 Trials studying Epilepsy
76 Patients Enrolled for Epilepsy
Bradley D. Vince, DOPrincipal InvestigatorVince & Associates Clinical Research, Inc.
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