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N/A N=82

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

Epilepsy

Enrolled (actual)
82
Serious AEs
Results posted
Mar 2009
Primary outcome: Primary: Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
sodium valproate (Drug)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Desitin Arzneimittel GmbH
Primary completion
Apr 2006

Outcome Measures

OutcomeResultp-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

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.

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
View full record on ClinicalTrials.gov →

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.

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