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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01114854
Other study ID # 538P108
Secondary ID
Status Completed
Phase Phase 1
First received April 28, 2010
Last updated May 16, 2017
Start date June 2010
Est. completion date January 2011

Study information

Verified date May 2017
Source Supernus Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Topiramate IR

Topiramate ER


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Supernus Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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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