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A Phase 3, Placebo-Controlled Study to Investigate LP352 in Children and Adults With Dravet Syndrome (DS)
EU CTIS ID: 2024-514937-39-00
What this study is testing
To evaluate the efficacy of LP352 in Dravet Syndrome as assessed by countable motor seizures
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant is ≥2 to ≤65 years of age at the time of Screening
- Diagnosis of Dravet Syndrome according to International League Against Epilepsy definition and must fulfill all of the following criteria: a. Onset of seizures age >1 and <20 months in an otherwise healthy infant. b. History of at least 1 of the following seizure type(s): i. Prolonged generalized tonic-clonic ii. Hemiclonic iii. Myoclonic iv. Tonic v. Atonic vi. Atypical absence vii. Focal awareness viii. Nonconvulsive status epilepticus
- The following countable motor seizure types: a. Generalized tonic-clonic b. Tonic (bilateral) c. Clonic (bilateral) d. Atonic (bilateral) with truncal/leg involvement e. Focal motor (including hemiclonic) f. Focal to bilateral tonic-clonic
- Demonstrated an average of at least 4 countable motor seizures (as per inclusion criterion 3) per month for the 3 months prior to Screening
- Has been taking 1 to 4 ASMs at a stable dose for at least 4 weeks prior to Screening
- The participant must be willing and able to provide written informed consent.
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 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, as described in the protocol.
- 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)
See the full eligibility criteria
- Participant is ≥2 to ≤65 years of age at the time of Screening
- Diagnosis of Dravet Syndrome according to International League Against Epilepsy definition and must fulfill all of the following criteria: a. Onset of seizures age >1 and <20 months in an otherwise healthy infant. b. History of at least 1 of the following seizure type(s): i. Prolonged generalized tonic-clonic ii. Hemiclonic iii. Myoclonic iv. Tonic v. Atonic vi. Atypical absence vii. Focal awareness viii. Nonconvulsive status epilepticus
- The following countable motor seizure types: a. Generalized tonic-clonic b. Tonic (bilateral) c. Clonic (bilateral) d. Atonic (bilateral) with truncal/leg involvement e. Focal motor (including hemiclonic) f. Focal to bilateral tonic-clonic
- Demonstrated an average of at least 4 countable motor seizures (as per inclusion criterion 3) per month for the 3 months prior to Screening
- Has been taking 1 to 4 ASMs at a stable dose for at least 4 weeks prior to Screening
- The participant must be willing and able to provide written informed consent.
- 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 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, as described in the protocol.
- 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 (other than the disease being studied; e.g., recurrent strokes), psychiatric, cardiovascular (e.g., 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.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Serbia
- Australia
- United States
- China
- Brazil
- United Kingdom
- Mexico
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Serbia; Australia; United States; China; Brazil and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.