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These are clinical trials for epilepsy in which SCN2A patients with seizures may be eligible to participate. This list is provided courtesy of the Mid-Atlantic Epilepsy and Sleep Center in Bethesda, Maryland, but the trials may have other sites closer to you. If you are interested, please contact the MAESC clinical trials team at 301-530-0046 or email Amanda Pong, MD (ponga@epilepsydc.com), Arkady Barber (barbera@epilepsydc.com) and Salman Hasmi (hashmis@epilepsydc.com). Copy all three of them if you choose to use email.

Clinical trials in epilepsy / See if you qualify

Mid-Atlantic Epilepsy and Sleep Center, LLC
6410 Rockledge Drive, #610
Bethesda, MD 20817
Phone: 301-530-9744
Fax: 301-530-0046
Research Coordinators: Arkady Barber and Salman Hashmi

There are several new treatments for epilepsy in development. They can often help patients whose seizures are not completely controlled with their drugs. Learn more below about epilepsy clinical trials at our center.

Clinical trials are performed for patients to gain access to new medications that can provide better seizure coverage with less side effects. All medications are approved by the FDA before they can be available to patients. In order for new medications to be approved by the FDA and available for use, clinical trials are needed before a medication becomes publicly available. These trials are all developed together with the FDA.

Epilepsy patients may be eligible for the following clinical trials at our center. If you are interested, please contact us to see whether this may be a good study for you. Travel reimbursement and compensation will be provided.

For Children and Adults:

SOTICLESTAT

• • TAK-935 works on the cholesterol pathway in the brain to decrease seizures. It also has anti-inflammatory and neuroprotective effects.
• • This is a double-blind, randomized, placebo-controlled clinical trial.
• • Pediatric and adult patients with Lennox Gastaut Syndrome from 2-55 years of age are eligible.
• • The safety, efficacy and tolerability will be studied.
• • The trial duration is about 23 weeks.

CARISBAMATE

• • Carisbamate works in a unique way to combat seizures.
• • This is a double-blind, randomized, placebo-controlled clinical trial.
• • Pediatric and adult patients with Lennox Gastaut Syndrome from 4-55 years of age are eligible.
• • The safety, efficacy and tolerability will be studied.
• • Patients who complete the study may be eligible for an open-label extension trial.
• • The trial duration is about 23 weeks.

LONGBOARD

• • LP-352 works at the serotonin pathway to decrease seizure activity.
• • This is a double-blind, randomized, placebo-controlled clinical trial.
• • Adult patients with developmental epileptic encephalopathies such as Lennox Gastaut Syndrome, Dravet Syndrome, CDKL-5 deficiency disorder, as well as tuberous sclerosis complex from 12-65 years of age are eligible.
• • The safety, tolerability and efficacy will be studied.
• • The trial duration is about 22 weeks.

LORCASERIN

• • Lorcaserin works at the serotonin pathway to decrease seizure activity.
• • This is a double-blind, randomized, placebo-controlled clinical trial.
• • Pediatric and adult patients with Dravet Syndrome from 2 years of age and older are eligible.
• • The safety, tolerability and efficacy will be studied.
• • Patients who complete the study may be eligible for an open-label extension trial.
• • The trial duration is about 15 months.

CENOBAMATE

• • Cenobamate has been an exceptionally effective medication for adults with epilepsy. It has led to seizure freedom in over 20% of patients. It is now being studied for use in children.
• • This is an open label safety and efficacy phase 3 study with open-label extension, where patients can receive the medication after the trial ends, if desired.
• • Children with focal (partial onset) seizures aged 2-17 years old are eligible.
• • Safety and tolerability will be studied.
• • Total duration is about 6 months, followed by open-label extension.

STACCATO ALPRAZOLAM

• • Prolonged seizures or seizure clusters require rapid, effective treatments that can be given easily by a caregiver. This medication (also known as Xanax, which has been used since the 1970’s) will be delivered through a new device where patients breathe in the medication, similar to asthma inhalers. This causes the medication to act very fast compared to other rescue medications.
• • This is an open-label study in patients 12 years and older with prolonged seizures or clusters of seizures.
• • Every participant will receive a single dose of the medication (no seizures required) to study how the medication is absorbed.

GANAXOLONE

• • Ganaxolone has a unique way of targeting the GABAA receptor pathway that may be affected in tuberous sclerosis complex (TSC), and prior studies showed reduction in seizures in TSC patients.
• • This is a phase 3, double-blind, randomized clinical trial to study the effects of ganaxolone on epilepsy in TSC.
• • Patients with TSC, between 1 to 65 years of age, and with epilepsy refractory to > 2 antiseizure medications are eligible.
• • The study duration is about 20 weeks.
• • After the trial, there is an open-label extension, during which patients may receive the treatment at no cost.

OPC-214870

• • OPC-214870 is being evaluated for effectiveness in adults with treatment resistant focal (partial onset) epilepsy.
• • This is a randomized, double-blind, placebo-controlled trial.
• • Patients from 16 and 64 years old, with a diagnosis of focal (partial onset)epilepsy may be eligible.
• • The study is evaluating the efficacy, safety, and tolerability of OPC-214870 50 mg or 200 mg compared to placebo in adults with treatment resistant focal epilepsy.
• • The trial duration is about 10 weeks.

For adults (over age 18 years):

JNJ 40411813

• • Several antiseizure medications are often used to control seizures in an individual and levetiracetam is a commonly used medication. The new drug JNJ 40411813 added to levetiracetam increases the response to levetiracetam by 25 times. This trial will study the effects of the drug on seizures in patients treated with levetiracetam or other anti-epileptic drugs.
• • This is a double-blind, randomized, placebo-controlled clinical trial.
• • Adults with focal (partial onset) seizures 18 to 69 years of age are eligible.
• • The safety, efficacy and tolerability will be studied.
• • The trial duration is about 22 weeks.

XEN 1101

• • Xen 1101 works in a new way and has shown very high effectiveness in studies so far.
• • This is the last, large study, a phase 3, double-blind, randomized clinical trial to study the effects of Xen 1101 on seizures in patients with focal (partial onset) epilepsy that is not completely controlled with other drugs.
• • Adults with focal epilepsy 18 to 75 years of age are eligible.
• • The safety, efficacy and tolerability will be studied.
• • Patients who complete the study may be eligible for an open-label extension trial.
• • The trial is about 6 months.

DARIGABAT

• • Benzodiazepines (drugs such as valium) are often used for seizure control, but are accompanied by many side effects including sleepiness. Darigabat works similarly but avoids many of these side effects.
• • This is a double-blind, placebo-controlled trial with an open label extension to assess the safety and efficacy of adjunctive CVL-865 in individuals with drug-resistant focal (partial onset) seizures.
• • Patients with epilepsy with focal onset and motor components for at least two years, average 4 seizures per month for 3 months, between 18-75 years old are eligible.
• • Safety, tolerability, and efficacy of the treatment will be studied.
• • Total duration is about 6 months.

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