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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01284530
First received: January 25, 2011
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Epilepsy
Drug: TPM XR
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Pharmacokinetics, Safety, and Tolerability of TPM XR as Adjunctive Therapy in Pediatric Subjects With Epilepsy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Relating to repeated oral dosing


Enrollment: 30
Study Start Date: January 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Conversion Drug: TPM XR
Equivalent TDD in XR form, QD, for 22-39days

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT01284530

Locations
United States, California
Sacramento, California, United States, 95815
United States, Florida
Loxahatchee, Florida, United States, 33470
Miami, Florida, United States, 33155
United States, Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, New Jersey
Hackensack, New Jersey, United States, 07601
United States, Ohio
Akron, Ohio, United States, 4308
United States, Texas
Dallas, Texas, United States, 75230
United States, Virginia
Norfolk, Virginia, United States, 23510
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
Study Director: Jennifer Stocks Supernus Pharmaceuticals
  More Information

No publications provided

Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01284530     History of Changes
Other Study ID Numbers: 538P107
Study First Received: January 25, 2011
Last Updated: June 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Supernus Pharmaceuticals, Inc.:
Epilepsy
Pediatrics
Young Adults

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 26, 2014