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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | epilepsy patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sodium valproate | Drug | valproate sustained release minitablets, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily | 7 weeks | |
| Number of Seizures Within 7 Weeks | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Data About Efficacy, Safety and Compliance | 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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community sample outpatients
In total 82 patients were included in this trial. The patients were naive or changed from another antiepileptic or valproate preparation to valproate sustained release minitablets once daily in the evening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Valproate | Epilepsy patients receive valproate sustained release minitablets, once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Valproate | Epilepsy patients receive valproate sustained release minitablets, once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily | Not Posted | number of seizures | 7 weeks | ||||||||||||
| Secondary | Data About Efficacy, Safety and Compliance | Not Posted | 7 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lohmueller | Desitin | 0049(0)40-59101 | 373 | lohmueller@desitin.de |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Primary | Number of Seizures Within 7 Weeks | Posted | Mean | Standard Deviation | seizures | 7 weeks |
|
|
|
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |