Dravet Syndrome (Myoclonic Epilepsy)

Condition Description

Dravet syndrome, previously called severe myoclonic epilepsy of infancy (SMEI), is an epilepsy syndrome that begins in infancy or early childhood and can include a spectrum of symptoms ranging from mild to severe. Children with Dravet syndrome initially show focal (confined to one area) or generalized (throughout the brain) convulsive seizures that start before 15 months of age (often before age one). These initial seizures are often prolonged and involve half of the body, with subsequent seizures that may switch to the other side of the body. These initial seizures are frequently provoked by seizures or exposure to increased temperatures or temperature changes, such as getting out of a bath. Other seizure types emerge after 12 months of age and can be quite varied. Status epilepticus – a state of continuous seizure requiring emergency medical care – may occur frequently in these children, particularly in the first five years of life.

Active Trials

Upcoming Trials

Past Trials

  • TRIAL TITLE: A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome.

    DESCRIPTION: The primary purpose of the study is to demonstrate that lorcaserin has superior efficacy compared to placebo on percent change in frequency of convulsive seizures per 28 days in participants with Dravet syndrome.

    SPONSOR: EISAI Inc.

    INDICATION: Dravet Syndrome (Myoclonic Epilepsy)

    STUDY PROTOCOL: E2023-A001-304

    PHASE: 3

    STATUS: Past

    ENROLLING PATIENTS: No

  • TRIAL TITLE: Extended Access Program With Lorcaserin For The Treatment of Dravet Syndrome and Other Refractory Epilepsies

    DESCRIPTION: The primary purpose of this study is to provide continued access of lorcaserin to participants with Dravet syndrome and other refractory epilepsies.

    SPONSOR: EISAI Inc.

    INDICATION: Dravet Syndrome (Myoclonic Epilepsy), Drug Resistant Epilepsy

    STUDY PROTOCOL: E2023-A001-405

    PHASE: 4, Expanded Access

    STATUS: Past

    ENROLLING PATIENTS: No

  • TRIAL TITLE: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies (ELEKTRA)

    DESCRIPTION: The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.

    SPONSOR: Ovid Therapeutics, Inc.

    INDICATION: Dravet Syndrome (Myoclonic Epilepsy), Epilepsy, Lennox-Gastaut Syndrome

    STUDY PROTOCOL: TAK 935-2002

    PHASE: 2 DB

    STATUS: Completed

    ENROLLING PATIENTS: No

  • TRIAL TITLE: Assessment of Potential for Chronic Liver Injury in Participants Treated With Epidiolex (Cannabidiol) Oral Solution

    DESCRIPTION: This study will monitor for potential chronic liver injury and liver fibrosis, in participants treated with cannabidiol oral solution.

    SPONSOR: Jazz Pharmaceuticals

    INDICATION: Lennox Gastaut Syndrome, Dravet Syndrome (Myoclonic Epilepsy), Tuberous Sclerosis Complex

    STUDY PROTOCOL: Illuminate GWEP19022

    PHASE: 4

    STATUS: Past

    RECRUITING PATIENTS: No