Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening|
- Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
- Number of Seizures Within 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
- Data About Efficacy, Safety and Compliance [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Study Completion Date:||April 2006|
|Primary Completion Date:||April 2006 (Final data collection date for primary outcome measure)|
Drug: sodium valproate
valproate sustained release minitablets, once daily.
Other Name: Orfiril (R) long