Summary

Eligibility
for people ages 2-65 (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The main purpose of this study is to investigate the long-term safety and tolerability of TAK-935/OV935 as an adjunctive therapy in patients with rare epilepsies.

Details

The drug being tested in this study is called TAK-935 (OV935). This global, open-label study will assess the safety and tolerability of TAK-935 for 2 years in patients who participated in previous short-term efficacy/safety studies of TAK-935. All patients will receive TAK-935 treatment. Patients who rollover from previous blinded study will undergo up to 0 to 2 weeks of Dose Optimization Period (depending on the previous study) followed by 103-weeks of Maintenance Period. Patients who rollover from an open-label study will continue on their current dose for 103-weeks. There will be a 4-week safety follow-up after the last dose, including a 2-week dose tapering period.

Keywords

Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Dup15q Syndrome, CDKL5 Deficiency Disorder Epilepsy Epilepsies, Myoclonic Lennox Gastaut Syndrome TAK-935

Eligibility

You can join if…

Open to people ages 2-65

  1. Participants must have participated in a previous TAK-935 study and meet one of the following conditions:
  2. Successfully completed a TAK-935 clinical study
  3. In the opinion of the investigator, the participant has the potential to benefit from the administration of TAK-935

You CAN'T join if...

  1. Clinically significant disease, that, in the investigator's opinion, precludes study participation
  2. Enrollment in any other clinical trial involving an investigational drug, device, or treatment in the past 90 days (with the exception of an antecedent study involving TAK-935)

Locations

  • David Geffen School of Medicine at UCLA accepting new patients
    Los Angeles California 90095 United States
  • 21st Century Neurology accepting new patients
    Phoenix Arizona 85004 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT03635073
Phase
Phase 2
Study Type
Interventional
Last Updated