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

Completed

• Conditions: Epilepsy
• Interventions: Drug: sodium valproate

• Registration Number: NCT00870688
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Study First Submitted: 2009-01-09
• Results First Submitted: 2009-01-09
• Status Verified: 2009-02
• Study First Submitted QC: 2009-03-26
• Results First Submitted QC: 2009-03-26
• Study First Posted: 2009-03-27
• Results First Posted: 2009-03-27
• Last Update Submitted: 2009-05-19
• Last Update Posted: 2009-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	sodium valproate	epilepsy patients

Primary Outcome Measures

Name	Time	Method
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily	7 weeks
Number of Seizures Within 7 Weeks	7 weeks

Secondary Outcome Measures

Name	Time	Method
Data About Efficacy, Safety and Compliance	7 weeks