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

Phase 1

Completed

• Conditions: Epilepsy
• Interventions: Drug: TPM XR

• Registration Number: NCT01284530
• Lead Sponsor: Supernus Pharmaceuticals, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-25
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-27
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Disposition First Submitted: 2013-05-22
• Disposition First Submitted QC: 2013-06-04
• Disposition First Posted: 2013-06-12
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conversion-50	TPM XR	50 mg
Conversion-100	TPM XR	100 mg
Conversion-200	TPM XR	200 mg
Conversion-25	TPM XR	25 mg

Primary Outcome Measures

Name	Time	Method
steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability	14 days	Relating to repeated oral dosing