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This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Valtoco In Pediatric Subjects with Epilepsy | Experimental | 5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diazepam Nasal Spray [Valtoco] | Drug | 5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age | 0-6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Florida Clinical Research Group, LLC. | Gulf Breeze | Florida | 32561 | United States | ||
| Nicklaus Children's Hospital |
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| Miami |
| Florida |
| 33155 |
| United States |
| AdventHealth Research Institute | Orlando | Florida | 32803 | United States |
| Center for Rare Neurological Diseases | Norcross | Georgia | 30093 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Missouri Women & Children's Hospital | Columbia | Missouri | 65201 | United States |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | United States |
| Boston Children's Health Physicians | Hawthorne | New York | 10532 | United States |
| University of Rochester | Rochester | New York | 14623 | United States |
| Duke University Hospital | Durham | North Carolina | 27710 | United States |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75225 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | United States |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003975 | Diazepam |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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