Trials / Completed
CompletedNCT05626634
Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy
A Phase 2, Multicenter, Open-label, Long-term Safety Study of LP352 in Subjects With Developmental and Epileptic Encephalopathy Who Completed Study LP352-201 and Are Candidates for Continuous Treatment for Up to 52 Weeks
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Longboard Pharmaceuticals · Industry
- Sex
- All
- Age
- 12 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the long-term safety, tolerability, and efficacy of adjunctive therapy of LP352 in subjects with developmental and epileptic encephalopathies who completed participation in Study LP352-201.
Detailed description
This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental and epileptic encephalopathy who completed Study LP352-201. The study consists of a Screening Period (Day -1) and a 50-week open-label Treatment Period that includes a 15-day Up-titration Period (during which time subjects will titrate up to their highest tolerated doses) and an open-label Maintenance Period (48 weeks). The Treatment Period will be followed by a Down-titration/Taper Period (up to 15 days) and Follow-up Period (14 days after completion of down-titration). The starting dose of up-titration will be 6 mg TID. The target final maintenance doses are 6 mg TID, 9 mg TID, and 12 mg TID after a 15-day up-titration period, if tolerated.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LP352, bexicaserin | LP352 6 mg, 9 mg or 12 mg administered three times daily, orally or through G-tube |
Timeline
- Start date
- 2022-11-08
- Primary completion
- 2024-12-20
- Completion
- 2024-12-20
- First posted
- 2022-11-25
- Last updated
- 2025-12-03
Locations
28 sites across 2 countries: United States, Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05626634. Inclusion in this directory is not an endorsement.