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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114854
• Other study ID #: 538P108
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2010
• Last updated: May 16, 2017
• Start date: June 2010
• Est. completion date: January 2011

Study information

• Verified date: May 2017
• Source: Supernus Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Topiramate IR

• Topiramate ER

Locations

Country	Name	City	State
United States	James Kiely	Atlanta	Georgia
United States	Dr. Segal	Fort Lauderdale	Florida
United States	Dr. Sackellares	Gainesville	Florida
United States	Dr. Chumley	Lexington	Kentucky
United States	Victor Biton	Little Rock	Arkansas
United States	Mohammed Bari	National City	California
United States	Dr. Fisher	Oklahoma City	Oklahoma
United States	Kyle Patrick	Phoenix	Arizona
United States	Bassem El-Nabbout	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma		2 weeks
Secondary	relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma		2 weeks