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Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures

NCT02535091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1345

Last updated 2024-05-14

Study results available
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Summary

This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.

Conditions

  • Partial Epilepsy

Interventions

DRUG

YKP3089

see above

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

  • Marc Kamin, MD · SK Life Science, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-03
Primary Completion
2021-03-31
Completion
2022-02-07

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Chile
  • Czechia
  • Germany
  • Hungary
  • Mexico
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Sweden
  • Thailand
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02535091 on ClinicalTrials.gov