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

Information source: Desitin Arzneimittel GmbH
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Epilepsy

Intervention: sodium valproate (Drug)

Phase: N/A

Status: Completed

Sponsored by: Desitin Arzneimittel GmbH


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.

Clinical Details

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

Study design: Time Perspective: Prospective

Primary outcome:

Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily

Number of Seizures Within 7 Weeks

Secondary outcome: Data About Efficacy, Safety and Compliance


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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


Locations and Contacts

Additional Information

Starting date: January 2005
Last updated: May 19, 2009

Page last updated: August 20, 2015

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