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The purpose of the study is to assess the safety profile of the investigational medication, Depakote Sprinkle Capsules, in the treatment of partial seizures in children ages 3-10.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium (Depakote Sprinkle Capsules) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Partial Seizure Rate at Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | ||
| WASI | ||
| WPPSI-III |
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Inclusion Criteria:
Subject has diagnosis of partial seizures with/without secondary generalization, supported by:
Observed ictal events consistent with partial seizures with/without secondary generalization; Documented by reliable observers
1 of following 3:
Subject weighs at least 15 kg (33 lbs).
Parent/caregiver is able to keep an accurate seizure diary.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Medical Information 800-633-9110 | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurology Clinic, P.C. | Northport | Alabama | United States | |||
| St. Joseph's Hospital and Medical Center |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| BASC |
| UKU-Neurologic Assessment |
| Vital Signs |
| Clinical Laboratory Assessments |
| ECG |
| PK analysis |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Pediatric Epilepsy and Neurology Specialists | Tampa | Florida | United States |
| Child Neurology Associates, P.C. | Atlanta | Georgia | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 1062 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Texas Association of Pediatric Neurology, P.A. | San Antonio | Texas | United States |
| Monarch Medical Research | Norfolk | Virginia | 23510 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298-0211 | United States |
| Richard V. Colan, M.D., S.C. | Milwaukee | Wisconsin | 53226 | United States |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |