An observational study in Epilepsy, sponsored by Desitin Arzneimittel GmbH. Completed. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2009-05-20.
Sponsored by Desitin Arzneimittel GmbH · Observational
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.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's enrollment of 82 is below the median of 101 across 536 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Desitin Arzneimittel GmbH is the lead sponsor of 13 studies on the registry; none are open to participants now.
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community sample outpatients
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Exclusion Criteria:
epilepsy patients
Drug: sodium valproate
valproate sustained release minitablets, once daily.
Also known as: Orfiril (R) long
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
Time frame: 7 weeks
Number of Seizures Within 7 Weeks
Time frame: 7 weeks
Data About Efficacy, Safety and Compliance
Time frame: 7 weeks
| Milestone | Sodium Valproate |
|---|---|
| Started | 82 |
| Completed | 78 |
| Not completed | 4 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Death, unrelated | 1 |
| Withdrew: Granules in the stools | 1 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
| seizures | Sodium Valproate |
|---|---|
| Number of Seizures Within 7 Weeks | 1.6 ± 2.9 |
| Age, Categorical(Participants) | Sodium Valproate |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 61 |
| >=65 years | 20 |
| Age Continuous(years) | Sodium Valproate |
|---|---|
| Mean | 45.9 ± 23 |
| Sex: Female, Male(Participants) | Sodium Valproate |
|---|---|
| Female | 43 |
| Male | 39 |
No study locations are listed for this record.
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Desitin Arzneimittel GmbH