LP352 for Epilepsy

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of LP352, a new potential drug for treating seizures in children and adults with certain types of epilepsy, such as Dravet Syndrome and Lennox-Gastaut Syndrome. Participants will experience different phases, including dose adjustment, maintenance, and tapering off. The trial seeks individuals who have completed earlier studies with LP352 and have a reliable caregiver to assist them. As a Phase 3 trial, this is the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that LP352 is likely to be safe for humans?

Research has shown that LP352 is generally safe and easy to handle. In previous studies, participants taking LP352 usually did well, whether used alone or with other medications. It also poses a low risk of interfering with other drugs, making it suitable for those on multiple medications.

One study found that LP352 had positive effects and was safe for individuals with developmental and epileptic encephalopathies (DEE), a type of epilepsy. These results suggest that LP352 could be a promising treatment with a good safety record. However, individual experiences may vary, so discussing any concerns with a healthcare provider is recommended. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for epilepsy?

Unlike standard epilepsy treatments, which often focus on modulating neurotransmitter levels or stabilizing neuronal membranes, LP352 presents a novel approach that targets specific receptors in the brain, potentially offering a more precise method of controlling seizures. Researchers are excited about LP352 because it could minimize side effects typically associated with broader-acting epilepsy medications, such as drowsiness or cognitive impairment. Additionally, LP352's ability to be titrated to the highest tolerated dose may provide tailored efficacy for each patient, enhancing its therapeutic potential.

What evidence suggests that LP352 might be an effective treatment for epilepsy?

Research has shown that LP352, the investigational treatment in this trial, may help reduce seizures in people with developmental and epileptic encephalopathies (DEE). One study reported an average reduction in seizures by 69.1% to 82.4% among participants taking LP352. Another study found a 32.5% decrease in seizure frequency compared to a placebo. In an ongoing study where participants continue to take LP352, there was a median reduction of 59.3% in motor seizures, with more than half of the participants maintaining these improvements. These findings suggest that LP352 could be effective in managing seizures in DEE. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. aesnet.org aesnet.org/abstractslisting/lp352-a-5-ht2c-superagonist-has-broad-antiepileptic-activity-in-preclinical-seizure-models

lp352, a 5-ht2c superagonist, has broad antiepileptic activity in ... Exp 2: LP352 treatment reduced brain seizure activity an average of 69.1%. Exp 3: LP352 treatment produced an 82.4% reduction in brain seizure ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05364021

NCT05364021 | Study to Investigate LP352 in Subjects ... The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents

3. biospace.com biospace.com/longboard-pharmaceuticals-announces-positive-topline-data-from-the-pacific-study-a-phase-1b-2a-clinical-trial-for-bexicaserin-lp352-in-participants-with-developmental-and-epileptic-encephalopathies-dees

Longboard Pharmaceuticals Announces Positive Topline ... Overall, this represents a placebo-adjusted reduction in seizure frequency of 32.5%. The median change in countable motor seizure frequency from ...

4. neurology.org neurology.org/doi/10.1212/WNL.98.18_supplement.1771

A Randomized, Double-Blind, Placebo-Controlled, Multiple ... LP352 is a potent and selective 5-HT2c superagonist. LP352 is being developed for the treatment of developmental and epileptic encephalopathies.

5. prnewswire.com prnewswire.com/news-releases/lundbeck-to-present-new-data-on-bexicaserin-at-upcoming-congress-highlighting-long-term-impact-on-seizure-frequency-in-patients-with-rare-epilepsy-302537462.html

Lundbeck to present new data on bexicaserin at upcoming ... During the OLE, a median reduction of 59.3% in countable motor seizure frequency was observed, with 55% of participants experiencing sustained ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05626634

Open-label, Long-term Safety Study of LP352 in Subjects ... This Phase 2, multicenter, open-label, multiple-dose extension clinical study is designed to evaluate long-term safety of LP352 in subjects with developmental ...

7. aesnet.org aesnet.org/abstractslisting/lp352-has-negligible-cyp-or-p-glycoprotein-interaction-potential-minimizing-therapeutic-complexity-in-epilepsy-patients-with-a-high-burden-of-polypharmacy

lp352 has negligible cyp or p-glycoprotein interaction potential ... LP352 was safe and generally well-tolerated, alone or in combination with other probe substrates. Conclusions: Given LP352's disposition via ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06719141

NCT06719141 | A Study to Investigate LP352 in Children ... This (DEEp OCEAN Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 ...

9. trials.tscalliance.org trials.tscalliance.org/trials/NCT06149663

Intermediate-Size Expanded Access Protocol (EAP) for LP352 Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.