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

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Drug: TPM XR

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95815
  • Florida
    • Loxahatchee, Florida, United States, 33470
    • Miami, Florida, United States, 33155
  • Kansas
    • Wichita, Kansas, United States, 67214
  • Kentucky
    • Louisville, Kentucky, United States, 40202
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
  • Ohio
    • Akron, Ohio, United States, 4308
  • Texas
    • Dallas, Texas, United States, 75230
  • Virginia
    • Norfolk, Virginia, United States, 23510
    • Richmond, Virginia, United States, 23219

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conversion-25; 25 mg	Drug: TPM XR; Equivalent TDD in XR form, QD, Day 1-14
Experimental: Conversion-50; 50 mg	Drug: TPM XR; Equivalent TDD in XR form, QD, Day 1-14
Experimental: Conversion-100; 100 mg	Drug: TPM XR; Equivalent TDD in XR form, QD, Day 1-14
Experimental: Conversion-200; 200 mg	Drug: TPM XR; Equivalent TDD in XR form, QD, Day 1-14

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability	Relating to repeated oral dosing	14 days

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.
• Investigators: Study Director: Jennifer Stocks, Supernus Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 25, 2011
• First Submitted That Met QC Criteria: January 25, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): June 2, 2016
• Last Update Submitted That Met QC Criteria: May 12, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Epilepsy; Pediatrics; Young Adults
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 538P107