NCT06660394Active, not recruitingPhase 3
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Efficacy, Safety, and Tolerability of LP352 in the Treatment of Seizures in Children and Adults With Dravet Syndrome
Longboard Pharmaceuticals306 sites in 10 countries96 target enrollmentStarted: September 25, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Longboard Pharmaceuticals
- Enrollment
- 96
- Locations
- 306
- Primary Endpoint
- Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 2 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 at least 1 of the following seizure type(s): prolonged generalized tonic-clonic, hemiclonic, myoclonic, tonic, atonic, atypical absence, focal impaired awareness, nonconvulsive status epilepticus
- •The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral), clonic (bilateral), atonic (bilateral) with truncal/leg involvement, focal motor (including hemiclonic), and focal to bilateral tonic-clonic
- •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 (in the judgment of the investigator) 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 is currently using 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 (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy, orthostatic hypotension/tachycardia), 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.
Arms & Interventions
Placebo
Placebo Comparator
Placebo for LP352
Intervention: Placebo (Drug)
LP352
Experimental
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.
Intervention: LP352 (Drug)
Outcomes
Primary Outcomes
Frequency Percent Change in Countable Motor Seizures During Treatment Compared to Baseline
Time Frame: Baseline and up to 15 Weeks
The percent change from Baseline in countable motor seizure frequency during Treatment will be calculated as countable motor seizure frequency during Treatment minus countable motor seizure frequency during Screening and divided by seizure frequency during Screening and multiplied by 100 where each seizure frequency will be based on number of seizures.
Secondary Outcomes
- Safety and Tolerability of LP352(Up to 21 Weeks)
- Percentage of participants with ≥ 50% Reduction in countable motor seizures during Treatment compared to Baseline(Baseline and up to 15 Weeks)
- Frequency Percent Change in Countable Motor Seizures during Maintenance compared to Baseline(Baseline and up to 15 Weeks)
Investigators
Study Sites (306)
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