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

Supernus Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Epilepsy

Treatments: Drug: Topiramate ER; Drug: Topiramate IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114854

538P108

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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69 participants in 1 patient group

Topiramate IR followed by Topiramate ER

Other group

Description:

Dosing with IR followed by dosing with ER

Treatment:

Drug: Topiramate IR

Drug: Topiramate ER