N/A
Completed N=82
Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
Source: ClinicalTrials.gov NCT00870688 ↗Enrolled (actual)
82
Serious AEs
—
Results posted
Mar 2009
Primary outcomePrimary: Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily |
— | — |
| PRIMARY Number of Seizures Within 7 Weeks |
1.6 | — |
| SECONDARY Data About Efficacy, Safety and Compliance |
— | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00870688). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.