Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01284530 | Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy | PHASE1 | COMPLETED | 30 | — | — | Jan 1, 2011 | Jun 1, 2012 | Jun 2, 2016 | 10 | United States |
Relating to repeated oral dosing
| Arm | Type | Description |
|---|---|---|
| Conversion-25 | EXPERIMENTAL | 25 mg |
| Conversion-50 | EXPERIMENTAL | 50 mg |
| Conversion-100 | EXPERIMENTAL | 100 mg |
| Conversion-200 | EXPERIMENTAL | 200 mg |
| Name | Type | Description |
|---|---|---|
| TPM XR | DRUG | Equivalent TDD in XR form, QD, Day 1-14 |
Inclusion Criteria: 1. Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR. 2. Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generaliz...