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

NCT00870688 | Completed Results

• 1 other identifier: VPA 044/K
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

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

Keywords

valproate; epilepsy; compliance; sustained released minitablet; Orfiril long

Outcome Measures

Primary Outcomes (2)

• Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily

  7 weeks

• Number of Seizures Within 7 Weeks

  7 weeks

Secondary Outcomes (1)

• Data About Efficacy, Safety and Compliance

  7 weeks

Study Arms (1)

1

epilepsy patients

Drug: sodium valproate

Interventions

sodium valproate DRUG

valproate sustained release minitablets, once daily.

Also known as: Orfiril (R) long

1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample outpatients

You may qualify if:

• age of 12 years and above
• epilepsy patients
• indication to initiation / conversion to valproate sustained release minitablets once daily

You may not qualify if:

• contraindication to valproate use
• no indication for conversion to valproate sustained release minitablets once daily

Sponsors & Collaborators

• Desitin Arzneimittel GmbH: lead

MeSH Terms

Conditions

Epilepsy; Patient Compliance

Interventions

Valproic Acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids, Volatile; Fatty Acids; Lipids

Results Point of Contact

• Title: Lohmueller
• Organization: Desitin

lohmueller@desitin.de

0049(0)40-59101

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: March 27, 2009
• Study Start: January 1, 2005
• Primary Completion: April 1, 2006
• Study Completion: April 1, 2006
• Last Updated: May 20, 2009
• Results First Posted: March 27, 2009

Record last verified: 2009-02