Epilepsy
Conditions
Brief 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.
Interventions
DRUGTopiramate IR
DRUGTopiramate ER
Sponsors
Supernus Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
It was a open-label study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma | 2 weeks |
Countries
United States
Outcome results
None listed