LP352 for Dravet Syndrome

Recruiting at 90 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Longboard Pharmaceuticals

Must be taking: Antiseizure medications

Must not be taking: Cannabis products

Disqualifiers: Infantile spasms, Neurodegenerative disorders, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This (DEEp SEA Study) is a double-blind, randomized, placebo-controlled, multicenter study to investigate the efficacy, safety, and tolerability of LP352 in the treatment of seizures in children and adults with DS. The study consists of 3 main phases: Screening, Titration period, and Maintenance period, followed by a Taper period and Follow-Up. Participants will be randomized to LP352 or placebo. The total duration of the study will be approximately 24 months.

Will I have to stop taking my current medications?

The trial requires participants to have been taking 1 to 4 antiseizure medications at a stable dose for at least 4 weeks before the study, so you may need to continue your current antiseizure medications. However, if you are taking any exclusionary medications, you may need to stop those.

Eligibility Criteria

This trial is for children and adults with Dravet Syndrome, a severe form of epilepsy. Participants must be experiencing seizures despite current treatments. Specific details on who can or cannot participate are not provided here.

Inclusion Criteria

Diagnosis of DS must fulfill all of the following criteria: Participants with seizure onset age >1 and <20 months, The participant has a history of specific seizure types, The participant has a current occurrence of specific motor seizure types, The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening, The participant has been taking 1 to 4 antiseizure medications (ASMs) at a stable dose for at least 4 weeks prior to Screening, The participant, parent, or caregiver is willing and able to comply with completion of the diaries throughout the study, The participant must be willing and able to provide written informed consent

Exclusion Criteria

The participant has a history of infantile/epileptic spasms, The participant has been admitted to a medical facility for treatment of status epilepticus requiring mechanical ventilation within 3 months prior to Screening, The participant has a neurodegenerative disorder as indicated by magnetic resonance imaging or genetic testing, The participant has an acquired lesion/injury unrelated to the primary etiology that could contribute as a secondary cause of seizures, The participant is receiving exclusionary medications, The participant has used any cannabis product or cannabidiol that is not in oral solution/capsule/tablet form, not obtained from a government-approved dispensary, or contains ≥50% Delta-9-tetrahydrocannabinol (THC), The participant has unstable, clinically significant neurologic, psychiatric, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, hematopoietic, or endocrine disease or other abnormality which may impact the ability of the participant to participate or potentially confound the study results, The participant is unwilling to comply with any of the study requirements or timelines

Trial 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

4 weeks

Visit 2 - Visit 5

Maintenance

Participants maintain the highest tolerated dose of LP352

6 weeks

Visit 5 - Visit 8

Taper

Participants taper off the study medication

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LP352 (Other)

Trial Overview The study tests LP352 against a placebo to see if it's better at treating seizures in Dravet Syndrome patients. It's double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo during the trial.

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 2 - Visit 5), followed by maintenance period (Visit 5 - Visit 8) and then taper/down titration period.

Group II: Placebo Placebo Group 1 Intervention

Placebo for LP352

Who Is Running the Clinical Trial?

Longboard Pharmaceuticals

Lead Sponsor

Trials

5

Recruited

570+