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

Primary Purpose

Epilepsy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topiramate IR
Topiramate ER
Sponsored by
Supernus Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kyle Patrick
  • Victor Biton
  • Mohammed Bari
  • Dr. Segal
  • Dr. Sackellares
  • James Kiely
  • Bassem El-Nabbout
  • Dr. Chumley
  • Dr. Fisher

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Topiramate IR followed by Topiramate ER

Arm Description

Dosing with IR followed by dosing with ER

Outcomes

Primary Outcome Measures

relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma

Secondary Outcome Measures

relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma

Full Information

First Posted
April 28, 2010
Last Updated
May 16, 2017
Sponsor
Supernus Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01114854
Brief Title
A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
Official Title
A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Supernus Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
It was a open-label study
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Topiramate IR followed by Topiramate ER
Arm Type
Other
Arm Description
Dosing with IR followed by dosing with ER
Intervention Type
Drug
Intervention Name(s)
Topiramate IR
Other Intervention Name(s)
Topamax®
Intervention Type
Drug
Intervention Name(s)
Topiramate ER
Other Intervention Name(s)
SPN-538T
Primary Outcome Measure Information:
Title
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male or female patients with epilepsy on stable doses of topiramate. Able to voluntarily provide written informed consent to participate in the study. Use of an effective form of birth control if of child-bearing potential. Exclusion Criteria: Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease. Recent or recurrent suicidal thoughts or ideation. Clinically significant medical condition that may affect the safety of the subject. Females who are pregnant or lactating.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Baroldi, MD, PhD
Organizational Affiliation
Supernus Pharmaceuticals, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kyle Patrick
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Victor Biton
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mohammed Bari
City
National City
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Dr. Segal
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Dr. Sackellares
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
James Kiely
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Bassem El-Nabbout
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Dr. Chumley
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
20513
Country
United States
Facility Name
Dr. Fisher
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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