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

May 19, 2009 updated by: Desitin Arzneimittel GmbH

Non Interventional Trial of Valproate Sustained Release Minitablets 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

82

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample outpatients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
epilepsy patients
Drug: sodium valproate
valproate sustained release minitablets, once daily.
Other Names:
  • Orfiril (R) long

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
Time Frame: 7 weeks
7 weeks
Number of Seizures Within 7 Weeks
Time Frame: 7 weeks
7 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Data About Efficacy, Safety and Compliance
Time Frame: 7 weeks
7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Desitin Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

January 9, 2009

First Submitted That Met QC Criteria

March 26, 2009

First Posted (Estimate)

March 27, 2009

Study Record Updates

Last Update Posted (Estimate)

May 20, 2009

Last Update Submitted That Met QC Criteria

May 19, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VPA 044/K

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Clinical Trials on sodium valproate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe