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

• Status: Completed
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Supernus Pharmaceuticals, Inc.
• Treatments: Topiramate

Criteria

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.