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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03650452 | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies | PHASE2 | COMPLETED | 141 | — | — | Aug 8, 2018 | Jul 20, 2020 | Feb 18, 2021 | 44 | United States, Australia +6 |
| NCT02539134 | TAK-935 Multiple Rising Dose Study in Healthy Participants | PHASE1 | COMPLETED | 40 | — | — | Sep 1, 2015 | Apr 1, 2016 | Jul 12, 2017 | 1 | United States |
Seizure frequency per 28 days is defined as total number of seizures (convulsive seizures for DS, drop seizures for LGS) reported during the period divided by number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline is defined as (frequency of seizures per 28 days during maintenance period - frequency of seizures per 28 days at baseline) divided by frequency of seizures per 28 days at baseline multiplied by 100. Negative percent change from Baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | TAK-935 placebo-matching tablets, orally or via gastrostomy tube (G-tube)/percutaneous endoscopic gastrostomy (PEG), twice a day (BID) up to Week 20. |
| TAK-935 | EXPERIMENTAL | TAK-935 tablets orally or via G-tube/PEG tube, BID. Participants weighing \<60 kg received total daily dose of study drug calculated based on body weight. Participants weighing ≥60 kg at Baseline, were administered with 200 mg/day followed by 400 mg/day, then 600 mg/day, up to Week 20. |
| Part 1, Cohort 1: TAK-935 100 mg QD | EXPERIMENTAL | TAK-935 100 milligram (mg), solution, orally, once daily (QD) or TAK-935 placebo-matching solution, orally, QD for up to 14 days. |
| Part 1, Cohort 2: TAK-935 300 mg QD | EXPERIMENTAL | TAK-935 300 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. |
| Part 1, Cohort 3: TAK-935 300 mg BID | EXPERIMENTAL | TAK-935 300 mg, solution, orally, twice daily (BID) or TAK-935 placebo-matching solution, orally, BID for up to 10 days. |
| Part 1, Cohort 4: TAK-935 600 mg QD | EXPERIMENTAL | TAK-935 600 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 10 days. |
| Part 1, Cohort 5: TAK-935 400 mg QD | EXPERIMENTAL | TAK-935 400 mg, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. |
| Part 2, Cohort 6: TAK-935 Dose 1 | EXPERIMENTAL | TAK-935 first decided dose as determined from other TAK-935 trials and Cohorts 1 to 4 of Part 1, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. |
| Part 2, Cohort 7: TAK-935 Dose 2 | EXPERIMENTAL | TAK-935 second decided dose as determined from other TAK-935 trials and Cohorts 1 to 4 of Part 1, solution, orally, QD or TAK-935 placebo-matching solution, orally, QD for up to 14 days. |
| Name | Type | Description |
|---|---|---|
| TAK-935 | DRUG | TAK-935 tablets or mini-tablets. |
| Placebo | DRUG | TAK-935 placebo-matching tablets or mini-tablets. |
Inclusion Criteria: 1. Male and female participants aged greater than or equal to (\>=) 2 and less than or equal to (\<=) 17 years 2. Clinical diagnosis of DS or LGS 3. Weight of \>=10 kilogram (kg) at the Screening visit 4. Currently taking 1 to 4 anti-epileptic drugs (AEDs) at a stable dose 5. Fa...