A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)

May 16, 2017 updated by: Supernus Pharmaceuticals, Inc.

A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy

This multi-center, two-treatment study compares the pharmacokinetic profiles of Immediate Release (IR) and Modified Release (MR) formulations of Topiramate (TPM) in patients with epilepsy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Kyle Patrick
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Victor Biton
    • California
      • National City, California, United States, 91950
        • Mohammed Bari
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Dr. Segal
      • Gainesville, Florida, United States, 32607
        • Dr. Sackellares
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • James Kiely
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Bassem El-Nabbout
    • Kentucky
      • Lexington, Kentucky, United States, 20513
        • Dr. Chumley
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Dr. Fisher

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult male or female patients with epilepsy on stable doses of topiramate.
  2. Able to voluntarily provide written informed consent to participate in the study.
  3. Use of an effective form of birth control if of child-bearing potential.

Exclusion Criteria:

  1. Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
  2. Recent or recurrent suicidal thoughts or ideation.
  3. Clinically significant medical condition that may affect the safety of the subject.
  4. Females who are pregnant or lactating.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Topiramate IR followed by Topiramate ER
Dosing with IR followed by dosing with ER
Drug: Topiramate IR
Other Names:
  • Topamax®
Drug: Topiramate ER
Other Names:
  • SPN-538T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Supernus Pharmaceuticals, Inc.

Investigators

  • Study Director: Paolo Baroldi, MD, PhD, Supernus Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

May 16, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 538P108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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