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Depakote/Depakote Sprinkle

Phase 2

Pediatric Epilepsy | Small molecule | Neurology |Abbott Laboratories|Last Updated: Mar 28, 2008

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Depakote/Depakote Sprinkle · 1 trial · 1 indication

Phase 2 1
NCT00646711Pediatric Switch Study for Children and Adolescent Patients With EpilepsyPediatric Epilepsy
COMPLETED16 Analytics
PHASE2COMPLETED
Pediatric Switch Study for Children and Adolescent Patients With Epilepsy
Pediatric EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of seizures
2 weeks
Number of Adverse Events
2 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence Group IEXPERIMENTALDepakote Delayed Release/Depakote Sprinkle
Sequence Group IIEXPERIMENTALDepakote ER

Interventions

NameTypeDescription
Depakote Delayed-Release/Depakote SprinkleDRUGAdministered according to the subject's usual regimen.
Depakote ERDRUGDose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.
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Eligibility Criteria

Age Range6 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patient with a clinical diagnosis of epilepsy considered stable by the investigator. * Must be in good physical health, on the same dose of all medications, including Depakote and other AEDs, for 2 week period prior to randomization. * Minimum body weight of 37 ...

Countries:United States
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Frequently asked questions about Depakote/Depakote Sprinkle

What is Depakote/Depakote Sprinkle used for in pediatric epilepsy?

Depakote/Depakote Sprinkle is a small molecule being studied for the treatment of pediatric epilepsy. It is an investigational drug in clinical development for this condition, specifically in children and adolescents. The drug is not approved for this use and remains under investigation.

Who makes Depakote/Depakote Sprinkle?

Depakote/Depakote Sprinkle is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker ABT. The company is conducting clinical research to evaluate the drug's safety and efficacy in pediatric epilepsy patients.

What phase is Depakote/Depakote Sprinkle in?

Depakote/Depakote Sprinkle is in Phase 2 clinical development for pediatric epilepsy. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its effects in the target patient population.

What clinical trials is Depakote/Depakote Sprinkle in?

Depakote/Depakote Sprinkle has been studied in one completed clinical trial, NCT00646711, titled "Pediatric Switch Study for Children and Adolescent Patients With Epilepsy." This Phase 2 trial enrolled 16 participants in the United States, with a minimum age of 6 years, and included both male and female patients.

Is Depakote/Depakote Sprinkle the same as Depakote Sprinkle?

Yes, Depakote/Depakote Sprinkle is the same drug as Depakote Sprinkle. The name Depakote/Depakote Sprinkle is used to refer to the drug, which is also known by the shorter name Depakote Sprinkle. Both names refer to the same investigational small molecule being developed for pediatric epilepsy.