NCT00646711

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2003

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

March 25, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2008

Completed
Last Updated

March 28, 2008

Status Verified

March 1, 2008

Enrollment Period

10 months

First QC Date

March 25, 2008

Last Update Submit

March 25, 2008

Conditions

Pediatric Epilepsy

Outcome Measures

Primary Outcomes (2)

  • Number of seizures

    2 weeks

  • Number of Adverse Events

    2 weeks

Study Arms (2)

Sequence Group I

EXPERIMENTAL

Depakote Delayed Release/Depakote Sprinkle

Drug: Depakote Delayed-Release/Depakote Sprinkle

Sequence Group II

EXPERIMENTAL

Depakote ER

Drug: Depakote ER

Interventions

Depakote Delayed-Release/Depakote SprinkleDRUG

Administered according to the subject's usual regimen.

Also known as: ABT-711, Depakote DR, Depakote Sprinkle, divalproex sodium
Sequence Group I
Depakote ERDRUG

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

Also known as: ABT-711, Depakote Extended Release, divalproex sodium
Sequence Group II

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Richmond, Virginia, 23284, United States

Location

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 25, 2008

First Posted

March 28, 2008

Study Start

February 1, 2003

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

March 28, 2008

Record last verified: 2008-03

Locations

US(1)