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

NCT ID: NCT00870688

Last Updated: 2009-05-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 82 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2006-04-30

Brief 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.

Conditions

Epilepsy

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

1

epilepsy patients

sodium valproate

Intervention Type: DRUG

valproate sustained release minitablets, once daily.

Interventions

sodium valproate

valproate sustained release minitablets, once daily.

Intervention Type: DRUG

Other Intervention Names

Orfiril (R) long

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Desitin Arzneimittel GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Desitin Arzneimittel GmbH

Other Identifiers

VPA 044/K

Identifier Type: -

Identifier Source: org_study_id