This is a multicenter, Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study designed to measure the how well it works and safety of clemizole hydrochloride (EPX-100) as added on top of your current treatment therapy in children and adult participants with Dravet syndrome (DS).
Official registry: https://clinicaltrials.gov/study/NCT04462770 · Epygenix · enrollment listed as 150
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Clemizole HCl, or Placebo. The registry lists allocation as randomized. This is a multicenter, Phase 3, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study designed to measure the how well it works and safety of clemizole hydrochloride (EPX-100) as added on top of your current treatment therapy in children and adult participants with Dravet syndrome (DS).
They plan to enroll about 150 people at 86 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A 20-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of EPX-100 (Clemizole Hydrochloride) as Adjunctive Therapy in Children and Adult Participants With Dravet Syndrome (ARGUS Trial)
Interventions: Clemizole HCl, Placebo
Primary outcome (registry wording): Percent Change in Countable Motor Seizures Per 28 Days (CMS-28) in the Titration Plus Maintenance Periods Relative to Baseline
Krystle Rapchak
clinicaltrials@harmonybiosciences.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 55 sites outside the US on the same record
Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment.
NCT00060541 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery.
NCT01273129 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.
NCT01793168 · Official ClinicalTrials.gov record · Sanford Health
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary