Epilepsy
Conditions
Keywords
valproate, epilepsy, compliance, sustained released minitablet, Orfiril long
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.
Interventions
DRUGsodium valproate
valproate sustained release minitablets, once daily.
Sponsors
Desitin Arzneimittel GmbH
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Data About Efficacy, Safety and Compliance | 7 weeks |
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Sodium Valproate Epilepsy patients receive valproate sustained release minitablets, once daily. | 82 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death, Unrelated | 1 |
| Overall Study | Granules in the Stools | 1 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Sodium Valproate |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 20 Participants |
| Age, Categorical Between 18 and 65 years | 61 Participants |
| Age Continuous | 45.9 years STANDARD_DEVIATION 23 |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 39 Participants |
Outcome results
Primary
Change in Number of Seizures After Conversion To Valproate Retard Minitablets Once Daily
Time frame: 7 weeks
Primary
Number of Seizures Within 7 Weeks
Time frame: 7 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sodium Valproate | Number of Seizures Within 7 Weeks | 1.6 seizures | Standard Deviation 2.9 |
Secondary
Data About Efficacy, Safety and Compliance
Time frame: 7 weeks