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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

It was a open-label study

Study Groups

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Topiramate IR followed by Topiramate ER

Dosing with IR followed by dosing with ER

Group Type OTHER

Topiramate IR

Intervention Type DRUG

Topiramate ER

Intervention Type DRUG

Interventions

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Topiramate IR

Intervention Type DRUG

Topiramate ER

Intervention Type DRUG

Other Intervention Names

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Topamax® SPN-538T

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No