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OpenTrials
Completed

NCT Number: NCT00870688

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Valproate

Drug

valproate sustained release minitablets, once daily.

Other names: Orfiril (R) long

Primary outcomes

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

    Time frame: 7 weeks

  2. Number of Seizures Within 7 Weeks

    Time frame: 7 weeks

Secondary outcomes

  1. Data About Efficacy, Safety and Compliance

    Time frame: 7 weeks

Sponsors and collaborators

Lead sponsor

Desitin Arzneimittel GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Mar 27, 2009
Registry last updated
May 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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