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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00870688
• Other study ID #: VPA 044/K
• Status: Completed
• Phase: N/A
• First received: January 9, 2009
• Last updated: May 19, 2009
• Start date: January 2005
• Est. completion date: April 2006

Study information

• Verified date: February 2009
• Source: Desitin Arzneimittel GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• sodium valproate
valproate sustained release minitablets, once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Desitin Arzneimittel GmbH

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily		7 weeks	No
Primary	Number of Seizures Within 7 Weeks		7 weeks	No
Secondary	Data About Efficacy, Safety and Compliance		7 weeks	Yes