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The ENACT Trial: A Randomized, double-blind, placebo-controlled adjunctive treatment trial to evaluate the efficacy and safety of ENX-101 in patients with focal (partial onset) seizures

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501028-95-00
Acronym
ENX-101-005
Enrollment
72
Registered
2022-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

focal (partial onset) epilepsy

Brief summary

The responder rate defined as the percent of patients who experience a 50% or greater reduction from baseline in seizure frequency in the Treatment Period compared to placebo

Detailed description

The median percent change from baseline in 28-day focal seizure frequency (focal aware motor with observable component, focal impaired awareness, or focal to bilateral tonic-clonic seizures) compared to placebo, The percent of patients who are seizure free during the last 28 days of the Treatment Period, The percent of patients who are seizure free during the entire Treatment Period

Interventions

DRUGENX-101 Placebo Capsule
DRUGENX-101 Placebo tablet

Sponsors

Engrail Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
The responder rate defined as the percent of patients who experience a 50% or greater reduction from baseline in seizure frequency in the Treatment Period compared to placebo

Secondary

MeasureTime frame
The median percent change from baseline in 28-day focal seizure frequency (focal aware motor with observable component, focal impaired awareness, or focal to bilateral tonic-clonic seizures) compared to placebo, The percent of patients who are seizure free during the last 28 days of the Treatment Period, The percent of patients who are seizure free during the entire Treatment Period

Countries

Belgium, Germany, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026