The study will also look at:
- If the study drug affects the general well-being of participants with Dravet syndrome.
- If there are any safety concerns for participants.
- How fast the study drug is removed from the body.
Up to 100 participants with Dravet syndrome will take part in this global study.
About The Argus Trial
The Argus Trial is being conducted to see if EPX-100 (Clemizole HCI) is able to decrease the number of convulsive seizures in participants with Dravet syndrome who are 2 years and older. The study will evaluate how often and what types of seizures are decreased in participants with Dravet syndrome as well as provide use questionnaires to evaluate how EPX-100 may affect the quality of life of participants with Dravet syndrome.
This is the first time that the study drug will be given to participants with Dravet syndrome, and your child will be carefully monitored for safety and efficacy during the study. Half of the participants will be given a placebo (drug-free oral liquid solution).
About Dravet Syndrome
Dravet syndrome is one of the most drug-resistant forms of epilepsy. Eighty percent (80%) of cases of Dravet syndrome are caused by a genetic mutation. However, the cause in other cases remains unknown. The disease usually appears during the first year and not only results in persistent seizures but causes very serious development symptoms such as sleep disturbances, delayed language, and motor development, among other concerns.
Argus Trial Quick Facts
The Argus study will have 3 phases: Screening, Titration, and Maintenance. Your child may participate in all 3 phases sequentially. The study doctors will share the details with you.
In the Screening phase, your child will need to visit the study center one time to receive a seizure calendar and instructions for the next 28 days. Your child will not receive any study drug at this stage, because this is just a way for the doctor to see how your child is doing with current medications.
In the Titration phase, your child will need to visit the study center for two visits and will receive 2 safety phone calls. Your child will be given increasing doses every week up to 80 mg twice a day. This phase will last for 4 weeks.
In the Maintenance phase, your child will need to visit the study center three times and will receive 2 safety phone calls. Your child will maintain the same treatment and you will need to fill in a seizure calendar during these 84 days of treatment. You will also be asked to answer questions as to how your child is doing.
Study Drug
The study drug is an oral solution form of EPX-100 (Clemizole HCl). Clemizole HCl is an antihistamine that was used in the past for the treatment of allergies. Studies of Dravet syndrome in the zebrafish model have shown that EPX-100 may have the potential to help reduce seizures in patients with Dravet syndrome.
Interested Parents and Caregivers
If your loved one has been diagnosed with Dravet syndrome and you are interested in learning if they may be eligible for participation in the Argus Trial, please reach out to clinicaltrials@harmonybiosciences.com and a representative from Harmony Biosciences will be in contact with you.
Study Locations
To find a clinical site near you, select a region below the
search box.
Please contact the study coordinator at the
nearest site listed or find contact information at https://clinicaltrials.gov/ct2/show/NCT04462770
Children’s Nebraska
8200 Dodge St Omaha, NE 68114
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Sookyong Koh
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402-559-2977
The Nemours Foundation
1600 Rockland Rd Wilmington, DE 19803
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Stephen Falcheck
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302-344-1528
University of Utah
201 South Presidents Circle, Rm 210 Salt Lake City, Utah 84112, United States
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Angela Peters
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801-585-9266
Seattle Children's Hospital
4800 Sand Point Way NE, M.B.7.420 Seattle, Washington 98105
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Julie Ziobro
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206-987-0058
Cincinnati Children’s Hospital Medical Center
3333 Burnet Avenue Suite ML 2015 Cincinnati, Ohio 45229
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Gewalin Aungaroon
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513-803-3177
Child Neurology Consultants of Austin
7940 Shoal Creek Boulevard Suite 100 Austin, Texas 78757
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Karen Keough
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210-416-4163
Wake Forest Baptist Medical Center
1 Medical Center Boulevard Winston-Salem, North Carolina 27157
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Gautam S. Popli
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336-716-2151
University of California, San Francisco Medical Center
550 16th Street 5th Floor San Francisco, California 94158
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Ernesto Gonzalez Giraldo
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415-353-8440
Cleveland Clinic
9500 Euclid Avenue Cleveland, Ohio 44195
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Elia Pestana-Knight
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216-636-5860
The Children’s Hospital of Philadelphia
The Hub for Clinical Collaboration 3550 Civic Center Blvd. 10th Floor Philadelphia, Pennsylvania 19104
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Eric Marsh
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215-419-3212
Weill Cornell Medical Center
505 East 70th Street Helmsley Tower, 3rd Floor New York, NY 10021
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Zachary Grinspan
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646-962-3023