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
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.
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 DailyNumber of Seizures Within 7 Weeks
Secondary outcome: Data About Efficacy, Safety and Compliance
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 2005
Last updated: May 19, 2009
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