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

Supernus Pharmaceuticals, Inc.69 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Epilepsy

Interventions

Topiramate IRDRUG

Topiramate ERDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (9)

Kyle Patrick

Phoenix, Arizona, United States

Victor Biton

Little Rock, Arkansas, United States

Mohammed Bari

National City, California, United States

Dr. Segal

Fort Lauderdale, Florida, United States

Outcomes

Primary Outcomes

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

Time frame: 2 weeks

Secondary Outcomes

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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