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Completed

NCT Number: NCT01114854

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

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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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kyle Patrick, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Topiramate IR

Drug

Other names: Topamax®

Topiramate ER

Drug

Other names: SPN-538T

Primary outcomes

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

    Time frame: 2 weeks

Secondary outcomes

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

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Supernus Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 3, 2010
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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