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

NCT ID: NCT01284530

Last Updated: 2016-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

Epilepsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conversion-25

25 mg

Group Type: EXPERIMENTAL

TPM XR

Intervention Type: DRUG

Equivalent TDD in XR form, QD, Day 1-14

Conversion-50

50 mg

Group Type: EXPERIMENTAL

TPM XR

Intervention Type: DRUG

Equivalent TDD in XR form, QD, Day 1-14

Conversion-100

100 mg

Group Type: EXPERIMENTAL

TPM XR

Intervention Type: DRUG

Equivalent TDD in XR form, QD, Day 1-14

Conversion-200

200 mg

Group Type: EXPERIMENTAL

TPM XR

Intervention Type: DRUG

Equivalent TDD in XR form, QD, Day 1-14

Interventions

TPM XR

Equivalent TDD in XR form, QD, Day 1-14

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Supernus Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Stocks

Role: STUDY_DIRECTOR

Supernus Pharmaceuticals

Locations

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

Countries

United States

Other Identifiers

538P107

Identifier Type: -

Identifier Source: org_study_id