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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

January 9, 2009
May 19, 2009
January 2005
April 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • Change in Seizure Rate Within the Last 7 Weeks Before Visit [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Number of Seizures Within 7 Weeks [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00870688 on ClinicalTrials.gov Archive Site
Data About Efficacy, Safety and Compliance [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening
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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

community sample outpatients

Epilepsy
Drug: sodium valproate
valproate sustained release minitablets, once daily.
Other Name: Orfiril (R) long
1
epilepsy patients
Intervention: Drug: sodium valproate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
April 2006
April 2006   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00870688
VPA 044/K
No
Karin Lohmueller, Desitin Arzneimittel GmbH
Desitin Arzneimittel GmbH
Not Provided
Not Provided
Desitin Arzneimittel GmbH
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP