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Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening

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ClinicalTrials.gov Identifier: NCT00870688
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : March 27, 2009
Last Update Posted : May 20, 2009
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH

Brief Summary:

Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals.

A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.


Condition or disease Intervention/treatment
Epilepsy Drug: sodium valproate

Study Type : Observational
Actual Enrollment : 82 participants
Time Perspective: Prospective
Official Title: Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening
Study Start Date : January 2005
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Group/Cohort Intervention/treatment
1
epilepsy patients
Drug: sodium valproate
valproate sustained release minitablets, once daily.
Other Name: Orfiril (R) long



Primary Outcome Measures :
  1. Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily [ Time Frame: 7 weeks ]
  2. Number of Seizures Within 7 Weeks [ Time Frame: 7 weeks ]

Secondary Outcome Measures :
  1. Data About Efficacy, Safety and Compliance [ Time Frame: 7 weeks ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample outpatients
Criteria

Inclusion Criteria:

  • age of 12 years and above
  • epilepsy patients
  • indication to initiation / conversion to valproate sustained release minitablets once daily

Exclusion Criteria:

  • contraindication to valproate use
  • no indication for conversion to valproate sustained release minitablets once daily

Responsible Party: Karin Lohmueller, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00870688     History of Changes
Other Study ID Numbers: VPA 044/K
First Posted: March 27, 2009    Key Record Dates
Results First Posted: March 27, 2009
Last Update Posted: May 20, 2009
Last Verified: February 2009

Keywords provided by Desitin Arzneimittel GmbH:
valproate
epilepsy
compliance
sustained released minitablet
Orfiril long

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
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