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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT #: 2005-004041-33 |
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Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.
Secondary objectives: Ancillary population kinetics study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valproate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| valproate microgranules | Drug | 20 to 30 mg/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and biological safety. | at each visit | |
| Pharmacokinetic parameters and covariables likely to explain the variability in the pharmacokinetic parameters of valproate | Ancillary population kinetics study |
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Inclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Marie SEBILLE, Dr | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Paris | France |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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