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Depakote/Depakote Sprinkle

Phase 2

Pediatric Epilepsy | Small molecule | Neurology |Abbott Laboratories|Trials 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

Depakote/Depakote Sprinkle clinical trials

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 used for?

Depakote is used for pediatric epilepsy. It is a small molecule therapy developed by Abbott Laboratories for children and adolescents with epilepsy. A Phase 2 pediatric switch study evaluated the drug in patients aged 6 years and older in the United States.

Who makes Depakote?

Depakote is made by Abbott Laboratories, which trades under the ticker ABT. Abbott is the developer associated with the Depakote and Depakote Sprinkle products for pediatric epilepsy.

What phase is Depakote in?

Depakote has been studied in Phase 2 clinical development for pediatric epilepsy. One Phase 2 trial has been completed, and no active trials are currently listed. The completed study enrolled 16 patients.

What clinical trials is Depakote in?

Depakote has been evaluated in the Phase 2 Pediatric Switch Study for Children and Adolescent Patients With Epilepsy, registered as NCT00646711. The trial was completed, enrolled 16 participants aged 6 years and older, and was conducted in the United States.

Is Depakote the same as Depakote Sprinkle?

Depakote and Depakote Sprinkle are related product names for the same therapy. Depakote is also known as Depakote Delayed-Release or Depakote Sprinkle, reflecting different formulations of the same small molecule developed by Abbott Laboratories.