Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial will evaluate the safety, tolerability, pharmacokinetics, and clinical activity of ABS-1230 compared with placebo in participants with KCNT1-related epilepsy
This is a Phase 1b/2 study that consists of 3 parts.
In part 1, participants will receive ABS-1230 for 12 weeks, with a follow-up period of 2 weeks.
In part 2, participants will receive ABS-1230 or placebo for 12 weeks, with a follow-up period of 2 weeks.
All participants who complete part 1 or part 2 will have the option to continue receiving ABS-1230 in an open-label extension study (part 3).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABS-1230 (Part 1) | Experimental |
| |
| ABS-1230 (Part 2) | Experimental |
| |
| Placebo (Part 2) | Experimental |
| |
| ABS-1230 (Part 3) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABS-1230 | Drug | Once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) | Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events | Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) |
| Part 2: Efficacy of ABS-1230 | Percentage change from baseline in countable motor seizures (normalized per 28 days) as recorded in the seizure diary | Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) |
| Part 3: Safety and tolerability of ABS-1230 (incidence and severity of adverse events) | Safety and tolerability of ABS-1230 by determining the incidence and severity of treatment emergent adverse events | Measured from Day 1 of Part 3 to End of Study or Early Termination (up to 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] of ABS-1230 | Pharmacokinetics of ABS-1230 | Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) |
| Total Exposure [AUCtau] ABS-1230 | Pharmacokinetics of ABS-1230 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Medical Director Actio Biosciences, Inc. | Contact | +1 (858) 682-4042 | info@actiobiosciences.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northeast Regional Epilepsy Group | Recruiting | Hackensack | New Jersey | 07601 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Part 1 will be open-label. Part 2 of the study will be conducted in a randomized double-blind manner. Part 3 will be an open-label extension.
| Placebo | Drug | Once daily |
|
| Measured from Day 1 to End of Study or Early Termination (up to 12 weeks) |