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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT03650452

NCT03650452
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • Children and teenagers between 2 and 17 years old (both boys and girls)
  • Have been diagnosed with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS)
  • Weigh at least 10 kilograms (about 22 pounds) at the screening appointment
  • Are currently taking between 1 and 4 seizure medications, all at a steady, unchanged dose
  • Have tried at least 2 different seizure medications in the past but were still unable to become and stay seizure-free

Who may not be able to join:

  • Have been admitted to a hospital and placed on a breathing machine (intubated) for a severe, prolonged seizure (status epilepticus) 2 or more times in the 3 months before the screening visit
  • Have episodes that look like seizures but may not actually be epileptic seizures, and doctors cannot reliably tell the difference between the two
  • Have taken part in another clinical trial involving a different experimental drug within the past month

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Takeda
Registry
clinicaltrials_gov
Start date
8 August 2018
Est. completion
9 June 2020

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇨🇳 China 🇮🇱 Israel 🇵🇱 Poland 🇵🇹 Portugal 🇪🇸 Spain 🇺🇸 United States

2 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percent Change From Baseline in Seizure Frequency Per 28 Days During the Maintenance Period

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov