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

This study has been completed.
Sponsor:
Information provided by:
Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier:
NCT00870688
First received: January 9, 2009
Last updated: May 19, 2009
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention
Epilepsy
 Drug: sodium valproate

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non Interventional Trial of Valproate Sustained Release Minitablets Once Daily in the Evening

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Further study details as provided by Desitin Arzneimittel GmbH:

Primary Outcome Measures:
  • Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Number of Seizures Within 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Data About Efficacy, Safety and Compliance [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 82
Study Start Date: January 2005
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
epilepsy patients
 Drug: sodium valproate
valproate sustained release minitablets, once daily.
Other Name: Orfiril (R) long

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample outpatients

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Karin Lohmueller, Desitin Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT00870688     History of Changes
Other Study ID Numbers: VPA 044/K
Study First Received: January 9, 2009
Results First Received: January 9, 2009
Last Updated: May 19, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Desitin Arzneimittel GmbH:
valproate
epilepsy
compliance
sustained released minitablet
Orfiril long

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on June 17, 2013