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A Study of a Drug to be Used in Addition With Another Drug to Treat Adults With Uncontrolled Partial-onset Seizures

NCT03116828 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2020-06-16

Study results available
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Summary

A study of a drug to be used in addition with another drug to treat adults with Uncontrolled Partial-onset Seizures

Conditions

  • Epilepsy With Partial On-set Seizures

Interventions

DRUG

Eslicarbazepine acetate

eslicarbazepine acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)

DRUG

Eslicarbazepine Acetate

eslicarbazepine acetate acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Sr. Director Medical Affairs · Sumitomo Pharma America, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2019-06-06
Completion
2019-06-06
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT03116828 on ClinicalTrials.gov