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Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures

NCT01397968 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2022-04-11

Study results available
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Summary

This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs.

Also to evaluate the safety and tolerability of YKP3089.

Conditions

  • Partial Epilepsy

Interventions

DRUG

YKP3089

Capsule, dose to be titrated Tablet, dose to be titrated

DRUG

Placebo

Placebo capsule Placebo tablet

Sponsors & Collaborators

  • SK Life Science, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-06
Primary Completion
2013-06-30
Completion
2021-01-28

Countries

  • United States
  • India
  • Poland
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01397968 on ClinicalTrials.gov