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:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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
Experimental: Sequence Group I Depakote Delayed Release/Depakote Sprinkle	Drug: Depakote Delayed-Release/Depakote Sprinkle Administered according to the subject's usual regimen. Other Names: ABT-711 Depakote DR Depakote Sprinkle divalproex sodium
Experimental: Sequence Group II Depakote ER	Drug: Depakote ER Dose converted to 8-20% higher than Depakote DR or Depakote Sprinkle. Other Names: ABT-711 Depakote Extended Release divalproex sodium

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

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on February 12, 2012