NCT00870688

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

Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 82 (actual)
• Sponsor: Desitin Arzneimittel GmbH · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
DRUG	sodium valproate	valproate sustained release minitablets, once daily.

Timeline

• Start date: 2005-01-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2009-03-27
• Last updated: 2009-05-20
• Results posted: 2009-03-27