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

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: Topiramate IR; Drug: Topiramate ER

• Registration Number: NCT01114854
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-28
• Study First Submitted QC: 2010-04-30
• Study First Posted: 2010-05-03
• Study Start: 2010-06
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Topiramate IR followed by Topiramate ER	Topiramate ER	Dosing with IR followed by dosing with ER
Topiramate IR followed by Topiramate ER	Topiramate IR	Dosing with IR followed by dosing with ER

Primary Outcome Measures

Name	Time	Method
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma	2 weeks

Secondary Outcome Measures

Name	Time	Method
relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma	2 weeks

Trial Locations

Locations (9)

Dr. Segal; 🇺🇸 Fort Lauderdale, Florida, United States

Kyle Patrick; 🇺🇸 Phoenix, Arizona, United States

Dr. Chumley; 🇺🇸 Lexington, Kentucky, United States

Victor Biton; 🇺🇸 Little Rock, Arkansas, United States

Dr. Sackellares; 🇺🇸 Gainesville, Florida, United States

Bassem El-Nabbout; 🇺🇸 Wichita, Kansas, United States

Dr. Fisher; 🇺🇸 Oklahoma City, Oklahoma, United States

Mohammed Bari; 🇺🇸 National City, California, United States

James Kiely; 🇺🇸 Atlanta, Georgia, United States