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

Completed · Phase 1

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01114854

Run by

Supernus Pharmaceuticals, Inc.

People needed

69

Starts

2010-06-01

Expected to finish

2011-01-01

Last updated by the study team

2017-05-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Dr. Sackellares — Gainesville, Florida, United States
• James Kiely — Atlanta, Georgia, United States
• Bassem El-Nabbout — Wichita, Kansas, United States
• Dr. Chumley — Lexington, Kentucky, United States
• Dr. Fisher — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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