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Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy

NCT01284530•Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

Multidose, Open-label, Multi-center Study to examine the steady state pharmacokinetics of TPM XR, as well as, safety and tolerability of repeated oral dosing in pediatric subjects with epilepsy.

Eligibility

Age

4 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able to provide written IAF, as appropriate, with written informed permission (including ICF where required by regional laws or regulations) from the parent or LAR.
•2. Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy.
•3. Current AED therapy including a stable dose of TPM IR as either adjunctive or monotherapy. All AED therapy (including a Vagal Nerve Stimulator) must have been initiated more than one month prior to Visit 1 and doses must be stable for at least two weeks prior to Visit 1.
•4. No diagnosis of a progressive neurological disorder based on previous imaging.
•5. Weight within the 25 - 80% weight-for-age percentiles based on the National Center for Health Statistics Growth Charts, and not less than 15.0kg.
•6. Able and willing to swallow whole capsules.
•7. FOCP should either be sexually inactive for two weeks prior to the first dose and throughout the study or, if sexually active, will be using an effective birth control method.

Exclusion Criteria

•1. A documented history of status epilepticus in the past year or seizures secondary to conditions other than epilepsy.
•2. Use of either phenytoin or carbamazepine as current AEDs.
•3. Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial onset or primary generalized epilepsy.
•4. Current diagnosis of Major Depressive Disorder or any history of suicide intent and/or attempt.
•5. History or presence of clinically significant, chronic medical condition which, in the opinion of the Investigator, would preclude the subject from entering the study.
•6. History of substance abuse or dependence.
•7. Females who are pregnant or lactating.
•8. Use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of SM.

Locations (10)

Sacramento, California, United States

Loxahatchee Groves, Florida, United States

Miami, Florida, United States

Wichita, Kansas, United States

Louisville, Kentucky, United States

Hackensack, New Jersey, United States

Akron, Ohio, United States

Dallas, Texas, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

June 1, 2012

Last Updated

June 2, 2016

Enrollment

ACTUAL participants

Conditions

Epilepsy

Interventions

TPM XR

DRUG

Thalamus Seizure Detection With a Deep Brain Stimulator System

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Epilepsy; Seizure

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RECRUITINGPHASE1

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NCT02531880

Epilepsy

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 2, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Inclusion Criteria

Exclusion Criteria

Thalamus Seizure Detection With a Deep Brain Stimulator System

Investigation of Blood-Brain-Barrier Breakdown Using Manganese Magnetic Resonance Imaging in Drug-Resistant Epilepsy

Intracranial Investigation of Neural Circuity Underlying Human Mood

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