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Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion-25 | Experimental | 25 mg |
|
| Conversion-50 | Experimental | 50 mg |
|
| Conversion-100 | Experimental | 100 mg |
|
| Conversion-200 | Experimental | 200 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TPM XR | Drug | Equivalent TDD in XR form, QD, Day 1-14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability | Relating to repeated oral dosing | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Stocks | Supernus Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sacramento | California | 95815 | United States | |||
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| Loxahatchee Groves |
| Florida |
| 33470 |
| United States |
| Miami | Florida | 33155 | United States |
| Wichita | Kansas | 67214 | United States |
| Louisville | Kentucky | 40202 | United States |
| Hackensack | New Jersey | 07601 | United States |
| Akron | Ohio | 4308 | United States |
| Dallas | Texas | 75230 | United States |
| Norfolk | Virginia | 23510 | United States |
| Richmond | Virginia | 23219 | United States |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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