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

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ClinicalTrials.gov Identifier: NCT01114854
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Topiramate IR Drug: Topiramate ER Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: It was a open-label study
Primary Purpose: Treatment
Official Title: A Conversion Study to Determine the Relative Bioavailability of TPM MR vs TPM IR in Subjects With Epilepsy
Study Start Date : June 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
Drug Information available for: Topiramate

Arm Intervention/treatment
Topiramate IR followed by Topiramate ER
Dosing with IR followed by dosing with ER
Drug: Topiramate IR
Other Name: Topamax®

Drug: Topiramate ER
Other Name: SPN-538T




Primary Outcome Measures :
  1. relative bioavailability at steady-state of TPM MR and TPM IR, as determined by TPM levels in plasma [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. relative bioavailability of TPM MR immediately following switch from TPM IR, as determined by TPM levels in plasma [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01114854     History of Changes
Other Study ID Numbers: 538P108
First Posted: May 3, 2010    Key Record Dates
Last Update Posted: May 18, 2017
Last Verified: May 2017

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