A Conversion Study of Immediate Release (IR) and Modified Release (MR) Forms of Topiramate (TPM)
A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
1 other identifier
interventional
69
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2010
Shorter than P25 for phase_1
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
May 3, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMay 18, 2017
May 1, 2017
6 months
April 28, 2010
May 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma
2 weeks
Secondary Outcomes (1)
relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma
2 weeks
Study Arms (1)
Topiramate IR followed by Topiramate ER
OTHERDosing with IR followed by dosing with ER
Interventions
Eligibility Criteria
You may qualify if:
- Adult male or female patients with epilepsy on stable doses of topiramate.
- Able to voluntarily provide written informed consent to participate in the study.
- Use of an effective form of birth control if of child-bearing potential.
You may not qualify if:
- Diagnosis of status epilepticus, non-epileptic seizures, or any progressive CNS disease.
- Recent or recurrent suicidal thoughts or ideation.
- Clinically significant medical condition that may affect the safety of the subject.
- Females who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Kyle Patrick
Phoenix, Arizona, 85013, United States
Victor Biton
Little Rock, Arkansas, 72205, United States
Mohammed Bari
National City, California, 91950, United States
Dr. Segal
Fort Lauderdale, Florida, 33308, United States
Dr. Sackellares
Gainesville, Florida, 32607, United States
James Kiely
Atlanta, Georgia, 30342, United States
Bassem El-Nabbout
Wichita, Kansas, 67214, United States
Dr. Chumley
Lexington, Kentucky, 20513, United States
Dr. Fisher
Oklahoma City, Oklahoma, 73112, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paolo Baroldi, MD, PhD
Supernus Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Masking Details
- It was a open-label study
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
May 3, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2010
Study Completion
January 1, 2011
Last Updated
May 18, 2017
Record last verified: 2017-05