Pediatric Switch Study for Children and Adolescent Patients With Epilepsy - Full Text View

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00646711

Purpose

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

Condition	Intervention	Phase
Pediatric Epilepsy	Drug: Depakote Delayed-Release/Depakote Sprinkle Drug: Depakote ER	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Crossover Assignment, Safety Study
Official Title:	A 14 Day Randomized, Open-Label, Cross-Over, Single Center, Outpatient Study of Depakote Delayed-Release or Depakote Sprinkle vs. Divalproex Sodium Extended-Release in Child and Adolescent Patients With Epilepsy

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Drug Information available for: Divalproex sodium Valproic acid Valproate Sodium

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:

Number of seizures [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Number of Adverse Events [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	16
Study Start Date:	February 2003
Study Completion Date:	December 2003
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Sequence Group I: Experimental Depakote Delayed Release/Depakote Sprinkle	Drug: Depakote Delayed-Release/Depakote Sprinkle Administered according to the subject's usual regimen.
Sequence Group II: Experimental Depakote ER	Drug: Depakote ER Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646711

Locations

United States, Virginia

Richmond, Virginia, United States, 23284

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Sharon Stec, Assoc Director )
Study ID Numbers:	M02-461
Study First Received:	March 25, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00646711 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Diseases
Central Nervous System Depressants
Enzyme Inhibitors

Brain Diseases
Antimanic Agents
Valproic Acid
Pharmacologic Actions
Epilepsy
Therapeutic Uses
GABA Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 27, 2009