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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01114854
First received: April 28, 2010
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: Topiramate
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy

Resource links provided by NLM:


Further study details as provided by Supernus Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: June 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IR
Dosing with IR
Drug: Topiramate
Experimental: MR
Dosing with MR
Drug: Topiramate

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114854

Locations
United States, Arizona
Kyle Patrick
Phoenix, Arizona, United States, 85013
United States, Arkansas
Victor Biton
Little Rock, Arkansas, United States, 72205
United States, California
Mohammed Bari
National City, California, United States, 91950
United States, Florida
Dr. Segal
Fort Lauderdale, Florida, United States, 33308
Dr. Sackellares
Gainesville, Florida, United States, 32607
United States, Georgia
James Kiely
Atlanta, Georgia, United States, 30342
United States, Kansas
Bassem El-Nabbout
Wichita, Kansas, United States, 67214
United States, Kentucky
Dr. Chumley
Lexington, Kentucky, United States, 20513
United States, Oklahoma
Dr. Fisher
Oklahoma City, Oklahoma, United States, 73112
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
Study Director: Paolo Baroldi, MD, PhD Supernus Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01114854     History of Changes
Other Study ID Numbers: 538P108
Study First Received: April 28, 2010
Last Updated: May 22, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Anti-Obesity Agents
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014