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New treatment option for Dravet Syndrome
Official title A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
ClinicalTrials.gov ID: NCT06660394
What this study is testing
What is LP352?
LP352 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for dravet syndrome.
Also referred to as Bexicaserin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 65
You may be able to join if
- 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...
- The participant has a current occurrence of at least 1 of the following countable motor seizure types: generalized tonic-clonic, tonic (bilateral)...
- The participant has demonstrated an average of at least 4 countable motor seizures per month for the 3 months prior to Screening.
You likely can't join if
- 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...
- 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...
See the full eligibility 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...
- 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...
- 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.
- 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...
- The participant has unstable, clinically significant neurologic (other than the disease being studied, eg, recurrent strokes), psychiatric, cardiovascular (eg, pulmonary arterial hypertension, cardiac valvulopathy...
- The participant is unwilling to comply with any of the study requirements or timelines.
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Gulf Breeze, Florida, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Bethesda, Maryland, United States
- Rochester, Minnesota, United States
- Livingston, New Jersey, United States
- Morristown, New Jersey, United States
- New York, New York, United States
- Portland, Oregon, United States
- Memphis, Tennessee, United States
- Austin, Texas, United States
+ 72 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States and 86 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.