drugset / Trial / NCT03288129
Study to Evaluate the Efficacy and Safety of Perampanel as Monotherapy or First Adjunctive Therapy in Subjects With Partial Onset Seizures With or Without Secondarily Generalized Seizures or With Primary Generalized Tonic-Clonic Seizures
NaSingle-groupOpen-labelTreatment
Summary
This study will assess the retention rate of perampanel when given as monotherapy or first adjunctive therapy in participants with partial-onset seizures or primary generalized tonic clonic seizures. The study consists of 4 periods: a Screening Period (to start no earlier than 6 weeks before the first dose of study drug), a Titration Period (up to 13 weeks), a Maintenance Period (39 weeks), and a Follow-Up Period (4 weeks).
Timeline
- Start
- 2017-08-23
- Primary completion
- 2021-04-27
- Completion
- 2021-04-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Perampanel | Small molecule | 2 mg | Oral |
| Subject | Perampanel | Small molecule | 4 mg | Oral |
| Subject | Perampanel | Small molecule | 6 mg | Oral |
| Subject | Perampanel | Small molecule | 8 mg | Oral |
| Subject | Perampanel | Small molecule | 10 mg | Oral |
| Subject | Perampanel | Small molecule | 12 mg | Oral |