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Evaluation of Efficacy and Safety of OXC XR as Adjunctive Therapy for Partial Seizures

NCT00772603 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 366

Last updated 2014-02-11

Study results available
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Summary

Evaluation of the safety and efficacy of Oxcarbazepine XR as adjunctive treatment for adults with partial onset seizures

Conditions

  • Epilepsies, Partial

Interventions

DRUG

Placebo

Non-active tablet identical to study drug tablets

DRUG

2400mg SPN-804

tablets containing 600mg OXC XR, identical to non-active tablets

DRUG

1200mg SPN-804

two active tablets and two non-active tablets, all identical

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • Supernus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Janet K Johnson, PhD · Supernus Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2010-04-30
Completion
2010-11-30

Countries

  • United States
  • Bulgaria
  • Canada
  • Croatia
  • Mexico
  • Poland
  • Romania
  • Russia

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 NCT00772603 on ClinicalTrials.gov