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Pediatric Switch Study for Children and Adolescent Patients With Epilepsy

NCT ID: NCT00646711

Last Updated: 2008-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2003-12-31

Brief Summary

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To assess the tolerability of switching from Depakote Sprinkle Capsules or Depakote tablets to Depakote ER tablets in the pediatric population.

Detailed Description

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Conditions

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Pediatric Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence Group I

Depakote Delayed Release/Depakote Sprinkle

Group Type EXPERIMENTAL

Depakote Delayed-Release/Depakote Sprinkle

Intervention Type DRUG

Administered according to the subject's usual regimen.

Sequence Group II

Depakote ER

Group Type EXPERIMENTAL

Depakote ER

Intervention Type DRUG

Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.

Interventions

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Depakote Delayed-Release/Depakote Sprinkle

Administered according to the subject's usual regimen.

Intervention Type DRUG

Depakote ER

Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.

Intervention Type DRUG

Other Intervention Names

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ABT-711 Depakote DR Depakote Sprinkle divalproex sodium ABT-711 Depakote Extended Release divalproex sodium

Eligibility Criteria

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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 lbs.

Exclusion Criteria

* Six-month history of drug or alcohol abuse.
* Status epilepticus within 6 months prior to screening.
* Abnormal platelet or ALT/AST levels.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott

INDUSTRY

Sponsor Role lead

Responsible Party

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Abbott

Locations

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Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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M02-461

Identifier Type: -

Identifier Source: org_study_id