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14 Dravet Syndrome Trials
Power is an online platform that helps thousands of Dravet Syndrome patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Epidiolex for Epilepsy
Toronto, OntarioThe goal of this clinical trial is to learn the best way to switch children with Lennox-Gastaut Syndrome (LGS) or Dravet Syndrome (DS) taking 'artisanal' (non pharmaceutical-grade) cannabidiol (CBD) to Epidiolex for treatment of seizures. The main questions it aims to answer are:
* How well does a gradual switch from 'artisanal' CBD to Epidiolex work?
* Does the same dose of Epidiolex as 'artisanal' CBD work best?
* What side-effects or medical problems do participants have when switching from 'artisanal' CBD to Epidiolex?
Researchers will examine how successful switching from 'artisanal' CBD to Epidiolex is.
Participants will:
* Gradually increase their dose of Epidiolex and reduce their dose of 'artisanal' CBD until they are taking just Epidiolex
* Visit the clinic five times over 20 weeks for checkups and tests
* Keep a diary of their seizures, symptoms and the number of times they use a rescue seizure medication
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 4
Age:2 - 18
Sex:All
25 Participants Needed
LP352 for Epilepsy
Columbus, OhioThis (DEEp OLE Study) is a multicentre, open-label study to investigate the long-term safety, efficacy, tolerability, and pharmacokinetics (PK) of LP352 in the treatment of seizures in children and adults with DEE who completed Study LP352-301 or LP352-302. The study consists of 3 main phases: Screening, Titration period and Maintenance period, followed by a Taper period and Follow-Up. The total duration of the study will be approximately 14 months.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 66
Sex:All
324 Participants Needed
Transdermal CBD for Epilepsy
Boston, MassachusettsThis study is a preliminary open-label, single-arm Phase II investigation into the safety and efficacy of transdermal cannabidiol (CBD) delivered using GT4 skin bream technology in individuals diagnosed with Dravet and/or Lennox-Gastatu syndrome (DS and/or LGS). We aim to enroll 25 participants between the ages of 2 and 55 diagnosed with DS and/or LGS.
Transdermal delivery of cannabinoids may provide advantages over other traditional routes of administration. Noted advantages include avoidance of first pass metabolism which mitigates potentially dangerous drug-drug interactions due to delayed cannabinoid accumulation, and more stable and constant plasma cannabinoid concentrations. GT4 technology, uses emulsion technology containing penetrating agents, basement membrane disruptors, and vasodilators to overcome hydrophilic and lipophilic structures to open channels and transport cannabinoids deep into the dermis layer of the skin. Once in the dermis, vasodilators dilate the capillary bed to increase fluid dynamic flow into and out of the application site, delivering cannabinoids into the blood stream.
The primary objective is to investigate the safety and efficacy of CBD delivery with the A-Synaptic GT4 Transdermal Delivery System in individuals diagnosed with DS and/orLGS. Dr. Rotenberg will apply for and hold the expanded access IND for this study, as the sponsor is running this study as an investigator-initiated study.
The study consists of 11 visits over \~160 days, dosing begins at Visit #2.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:2 - 55
Sex:All
25 Participants Needed
Fenfluramine for Dravet Syndrome
Rochester, MinnesotaDravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav1.1, a protein necessary for sodium channels. Children with Dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. This creates some limitations in medication choices for this patient population. Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older. Randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. Additionally, 16% of children treated with fenfluramine were seizure free. Fenfluramine is likely to be as effective in children under the age of 2 years. The current study has proposed a treatment protocol to allow access to fenfluramine for children under 24 months of age.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:12 - 24
Sex:All
Key Eligibility Criteria
Disqualifiers:Mitral Regurgitation, Aortic Regurgitation, Failure To Thrive, Others
Must Not Be Taking:Sodium Channel Blockers
12 Participants Needed
LP352 for Dravet Syndrome
Columbus, OhioThis (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.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:2 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Infantile Spasms, Neurodegenerative Disorders, Others
Must Be Taking:Antiseizure Medications
160 Participants Needed
Fenfluramine for Dravet Syndrome
Winston-Salem, North CarolinaThe primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:1 - 23
Sex:All
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Glaucoma, Others
Must Be Taking:Antiseizure Medications
20 Participants Needed
ETX101 for Dravet Syndrome
Chicago, IllinoisENDEAVOR is a Phase 1/2, 2-part, multicenter study to evaluate the safety and efficacy of ETX101 in participants with SCN1A-positive Dravet syndrome aged ≥6 to \<36 months (Part 1) and aged ≥6 to \<48 months (Part 2). Part 1 follows an open-label, dose-escalation design, and Part 2 is a randomized, double-blind, sham delayed-treatment control, dose-selection study.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:6 - 47
Sex:All
Key Eligibility Criteria
Disqualifiers:Genetic Mutation, CNS Abnormality, Others
Must Be Taking:Antiseizure Medications
22 Participants Needed
Soticlestat for Dravet Syndrome
Toledo, OhioThis trial tests soticlestat to reduce seizures in children and adults with Dravet Syndrome or Lennox-Gastaut Syndrome. Soticlestat helps by targeting brain pathways involved in seizure activity. The study will evaluate its safety, effectiveness, and tolerance over time.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2 - 56
Sex:All
Key Eligibility Criteria
Disqualifiers:Unstable Neurologic, Psychiatric, Cardiovascular, Others
Must Be Taking:Anti-seizure Therapy
400 Participants Needed
Cannabidiol for Chronic Liver Injury Prevention
West Chester, OhioThis study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:1+
Sex:All
154 Participants Needed
Cannabidiol for Seizures
Cincinnati, OhioThis trial tests a medication called GWP42003-P in children under 2 years old who have severe seizure disorders like TSC, LGS, or DS. The study will last over a year and will check if the medication is safe, how it moves through the body, and if it helps reduce seizures. These conditions often don't respond well to usual treatments, so new options are needed. Cannabidiol (pharmaceutical) is approved by the FDA for the treatment of seizures associated with DS, Lennox-Gastaut syndrome, and tuberous sclerosis complex in patients ≥1 year of age.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:1 - 23
Sex:All
27 Participants Needed
STK-001 for Dravet Syndrome
Ann Arbor, MichiganThis trial is testing the safety of STK-001, a new treatment for Dravet syndrome. It aims to help patients by increasing a brain protein that is usually low in this condition. The study focuses on patients who have already tried this treatment in earlier studies.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Age:30+
Sex:All
60 Participants Needed
EPX-100 for Dravet Syndrome
Columbus, OhioThe purpose of this study is to evaluate the safety and efficacy of EPX-100 as adjunctive therapy in participants with Dravet syndrome.
Stay on current meds
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:2 - 80
Sex:All
Key Eligibility Criteria
Disqualifiers:Suicidal Thoughts, Cardiac Disease, Others
Must Be Taking:Aeds
100 Participants Needed
Fenfluramine for Dravet and Lennox-Gastaut Syndromes
Cleveland, OhioThis is an international, multicenter, open-label, long-term safety study of ZX008 in subjects with Dravet syndrome, Lennox-Gastaut syndrome or epileptic encephalopathy
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 3
Age:2+
Sex:All
412 Participants Needed
Soticlestat for Rare Epilepsies
Lexington, KentuckyThe main aim is to assess the long-term safety and tolerability of soticlestat when used along with other anti-seizure treatment.
Participants will receive soticlestat twice a day. Participants will visit the study clinic every 2-6 months throughout the study.
Study treatments may continue as long as the participant is receiving benefit from it.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:2 - 65
Sex:All
156 Participants Needed
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Frequently Asked Questions
How much do Dravet Syndrome clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Dravet Syndrome clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Dravet Syndrome trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Dravet Syndrome is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Dravet Syndrome medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Dravet Syndrome clinical trials ?
Most recently, we added Epidiolex for Epilepsy, LP352 for Epilepsy and Transdermal CBD for Epilepsy to the Power online platform.