Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
|ClinicalTrials.gov Identifier: NCT00870688|
Recruitment Status : Completed
First Posted : March 27, 2009
Results First Posted : March 27, 2009
Last Update Posted : May 20, 2009
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|
|Official Title:||Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening|
|Study Start Date :||January 2005|
|Primary Completion Date :||April 2006|
|Study Completion Date :||April 2006|
Drug: sodium valproate
valproate sustained release minitablets, once daily.
Other Name: Orfiril (R) long
- Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily [ Time Frame: 7 weeks ]
- Number of Seizures Within 7 Weeks [ Time Frame: 7 weeks ]
- Data About Efficacy, Safety and Compliance [ Time Frame: 7 weeks ]