LP352 for Epilepsy

Recruiting at 32 trial locations

Overseen By Longboard Study Contact

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Longboard Pharmaceuticals

Must be taking: LP352

Must not be taking: Cannabis, Cannabidiol

Disqualifiers: Neurologic, Psychiatric, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

324 Participants Needed

Trial Summary

What is the purpose of this trial?

This (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does exclude participants who are on certain medications. You should discuss your current medications with the study team to see if they are allowed.

Eligibility Criteria

This trial is for children and adults with Developmental and Epileptic Encephalopathy (DEE) who have completed previous studies LP352-301 or LP352-302. Participants should be able to follow the study schedule, which lasts about 14 months.

Inclusion Criteria

Participant has satisfactorily completed Study LP352-301 or LP352-302 Visit 8, and who, in the opinion of the investigator, may benefit from continued LP352 administration

Has at least one reliable and consistent parent, legal guardian, or caregiver during the study

Participant or legal representative must be willing and able to provide written informed consent

Exclusion Criteria

I am not taking any medications that would exclude me from the trial.

I use cannabis or CBD not in pill form, not from an approved source, or with high THC.

I do not have any major health issues that could affect my participation in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Titration

Participants are titrated up to the highest tolerated dose of LP352

6 weeks

3 visits (in-person)

Maintenance

Participants maintain the highest tolerated dose of LP352

49 weeks

11 visits (in-person)

Taper

Participants taper off the medication

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LP352

Trial Overview The trial is testing LP352's long-term safety and effectiveness in treating seizures associated with DEE. It includes a screening phase, titration period to adjust dosage, maintenance period for ongoing treatment, followed by a tapering off period and final follow-up.

Participant Groups

Group I: LP352 Experimental Treatment 1 Intervention

Participants will be titrated up to highest tolerated dose of LP352 during the Titration period (Visit 1 - Visit 3), followed by maintenance period (Visit 4 - Visit 14) and then taper/down titration period (Visit 15 - Visit 17).

Who Is Running the Clinical Trial?

Longboard Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

570+