Dravet Syndrome
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CLINICAL_TRIALS trial_result · 2025-10-31Clinical Trial Update: Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures [Phase 3]
A Phase 3 study of adjunctive cannabidiol oral solution GWP42003-P in children with tuberous sclerosis complex, Dravet syndrome, or Lennox-G…
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FDA approval · 2025-10-15FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for Fintepla (fenfluramine) by UCB, Inc. The action updates the product’s labeling as part of th…
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CLINICAL_TRIALS trial_result · 2025-10-08Clinical Trial Update: A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome [Phase 3]
A Phase 3 study of Soticlestat as add-on therapy for children and adults with Dravet syndrome or Lennox-Gastaut syndrome has been terminated…
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CLINICAL_TRIALS trial_result · 2025-10-08Clinical Trial Update: A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome [Phase 3]
Phase 3 study of lorcaserin as an adjunctive treatment for Dravet syndrome was terminated; results have been posted.
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CLINICAL_TRIALS trial_result · 2025-09-16Clinical Trial Update: Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ) [Phase 1]
This Phase 1 trial evaluated the bioavailability of stiripentol after a single oral dose, comparing capsule administration to suspension in …
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CLINICAL_TRIALS research · 2025-08-28Clinical Trial Update: A Study of EPX-100 (Clemizole Hydrochloride) in Participants With Dravet Syndrome [Phase 3]
EPX-100 (clemizole hydrochloride) is advancing to Phase 3 for Dravet syndrome and is currently recruiting participants.
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CLINICAL_TRIALS research · 2025-08-12Clinical Trial Update: BMB-101 in Absence Epilepsy and DEE [Phase 2]
Phase 2 clinical trial update for BMB-101 in absence epilepsy and developmental and epileptic encephalopathies, including Jeavons syndrome, …
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CLINICAL_TRIALS research · 2025-05-18Clinical Trial Update: An Open-Label Study to Investigate the Safety of Single and Multiple Ascending Doses in Children and Adolescents With Dravet Syndrome [Phase 1, Phase 2]
This entry reports the completion of an open-label Phase 1/2 study evaluating safety of single and multiple ascending doses of STK-001 in ch…
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CLINICAL_TRIALS research · 2025-04-17Clinical Trial Update: A Study to Gather Information About Overall Occurrence and New Cases of Dravet and Lennox-Gastaut Syndromes in Children, Teenagers and Adults in Spain
This completed Spanish registry study collected information on how often Dravet syndrome and Lennox-Gastaut syndrome occur and new cases acr…
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FDA approval · 2025-04-08FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)
FDA supplemental application for Fintepla (fenfluramine) submitted by UCB, Inc.
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CLINICAL_TRIALS trial_result · 2025-03-06Clinical Trial Update: A Study Evaluating Soticlestat in Participants With Dravet Syndrome or Lennox-Gastaut Syndrome Who Have Been Exposed to Fenfluramine [Phase 3]
Phase 3 trial evaluating soticlestat in Dravet syndrome or Lennox-Gastaut syndrome patients with prior fenfluramine exposure was terminated;…
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CLINICAL_TRIALS trial_result · 2025-01-30Clinical Trial Update: Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies
Clinical trial update describing an extended access program using lorcaserin to treat Dravet syndrome and other refractory epilepsies.
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CLINICAL_TRIALS research · 2025-01-22Clinical Trial Update: Intermediate-Size Expanded Access Protocol (EAP) for LP352
Update on Longboard Pharmaceuticals' expanded access protocol for LP352, indicating availability for patients with Dravet syndrome, Lennox-G…
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CLINICAL_TRIALS trial_result · 2025-01-01Clinical Trial Update: A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome [Phase 3]
Phase 3 study evaluating soticlestat as add-on therapy in children and young adults with Dravet syndrome has completed with results posted.
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CLINICAL_TRIALS research · 2024-12-18Clinical Trial Update: CBD Delivery with the A-Synaptic GT4 Transdermal Delivery System in with Dravet Syndrome And/or Lennox-Gastaut Syndrome [Phase 1, Phase 2]
This clinical trial update describes a Phase 1/Phase 2 study evaluating cannabidiol delivered via the A-Synaptic GT4 transdermal system for …
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CLINICAL_TRIALS research · 2024-12-10Clinical Trial Update: Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age [Phase 4]
Phase 4 clinical trial assessing the safety of fenfluramine in children with Dravet syndrome under 24 months; currently recruiting.
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CLINICAL_TRIALS trial_result · 2024-11-08Clinical Trial Update: Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies [Phase 1, Phase 2]
Clinical trial update indicates LP352 has completed Phase 1/2 studies in developmental and epileptic encephalopathies. The program covers Dr…
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CLINICAL_TRIALS withdrawal · 2024-10-03Clinical Trial Update: A Study on Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) in Children, Teenagers and Adults in Portugal
A Takeda-sponsored clinical trial investigating Dravet syndrome and Lennox-Gastaut syndrome in children, teenagers and adults in Portugal ha…
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CLINICAL_TRIALS trial_result · 2024-09-19Clinical Trial Update: Study of Safety and Pharmacokinetics of Oral Doses of EPX-100 in Healthy Subjects. [Phase 1]
Phase 1 safety and pharmacokinetics data for oral EPX-100 in healthy subjects. The study supports continued development for Dravet Syndrome.
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CLINICAL_TRIALS trial_result · 2024-08-02Clinical Trial Update: Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA
A retrospective non-interventional study evaluating stiripentol use in Dravet syndrome patients in the United States has been completed.
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CLINICAL_TRIALS research · 2024-07-16Clinical Trial Update: SCN1A Horizons A Natural History Study of SCN1A-related Epilepsies in the United Kingdom
ClinicalTrials.gov reports a UK natural history study of SCN1A-related epilepsies that is currently recruiting to better characterize diseas…
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FDA approval · 2024-04-02FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)
The FDA approved a supplemental application for Fintepla (fenfluramine) from UCB, Inc., authorizing additional regulatory approval for the d…
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FDA approval · 2024-03-04FDA Approved: EPIDIOLEX — Supplemental Application (Jazz Pharmaceuticals, Inc.)
The FDA approved a supplemental application for Epidiolex (cannabidiol) from Jazz Pharmaceuticals.
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FDA approval · 2023-12-11FDA Approved: FINTEPLA — Supplemental Application (UCB, Inc.)
FDA approved a supplemental application for FINTEPLA (fenfluramine) filed by UCB, Inc., expanding/adjusting its labeling and indications.
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CLINICAL_TRIALS trial_result · 2023-11-13Clinical Trial Update: A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome [Phase 3]
A Phase 3 trial evaluating the Embrace seizure detection watch in children and young adults with Dravet syndrome was terminated; results wer…