Epilepsy Clinical Trial
Official title:
A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
Verified date | May 2017 |
Source | Supernus Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | January 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | James Kiely | Atlanta | Georgia |
United States | Dr. Segal | Fort Lauderdale | Florida |
United States | Dr. Sackellares | Gainesville | Florida |
United States | Dr. Chumley | Lexington | Kentucky |
United States | Victor Biton | Little Rock | Arkansas |
United States | Mohammed Bari | National City | California |
United States | Dr. Fisher | Oklahoma City | Oklahoma |
United States | Kyle Patrick | Phoenix | Arizona |
United States | Bassem El-Nabbout | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Supernus Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma | 2 weeks | ||
Secondary | relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma | 2 weeks |
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