Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PRAX-628, vormatrogine, 30mg PRAX-628
Vormatrigine · 3 trials · 6 indications
Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs
Median percent change in monthly (28 days) seizure frequency from the Screening/Observation Period to the Treatment Period for PRAX-628
Geometric mean ratio (90% CI) for maximum observed plasma concentration (Cmax)
| Arm | Type | Description |
|---|---|---|
| Open-label 30 mg/day vormatrogine for up to 2 years | EXPERIMENTAL | Participants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years. |
| Open-label 30mg/day PRAX-628 for 8 weeks | EXPERIMENTAL | Participants who meet all eligibility criteria will receive 30mg of PRAX-628 for 8 weeks. |
| Single Oral Dose 40mg PRAX-628 tablet then 4x10mg PRAX-628 capsules | EXPERIMENTAL | 40 mg PRAX-628 tablet followed by 4×10 mg PRAX-628 capsules administered orally. |
| Single Oral Dose 4x10mg PRAX-628 capsules then 40mg PRAX-628 tablet | EXPERIMENTAL | 4×10 mg PRAX-628 capsules followed by 40 mg PRAX-628 tablet administered orally. |
| Name | Type | Description |
|---|---|---|
| vormatrogine | DRUG | Once daily oral |
| 30mg PRAX-628 | DRUG | Once daily oral |
| PRAX-628 | DRUG | Once daily oral |
Inclusion Criteria: * Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded acces...