NCT01284530

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 2, 2016

Status Verified

May 1, 2016

Enrollment Period

1.4 years

First QC Date

January 25, 2011

Last Update Submit

May 12, 2016

Conditions

Epilepsy

Keywords

EpilepsyPediatricsYoung Adults

Outcome Measures

Primary Outcomes (1)

  • steady-state pharmacokinetics (PK) of TPM XR and to assess the safety and tolerability

    Relating to repeated oral dosing

    14 days

Study Arms (4)

Conversion-25

EXPERIMENTAL

25 mg

Drug: TPM XR

Conversion-50

EXPERIMENTAL

50 mg

Drug: TPM XR

Conversion-100

EXPERIMENTAL

100 mg

Drug: TPM XR

Conversion-200

EXPERIMENTAL

200 mg

Drug: TPM XR

Interventions

TPM XRDRUG

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

Conversion-100Conversion-200Conversion-25Conversion-50

Eligibility Criteria

Age4 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.
  • Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset or primary generalized epilepsy.
  • 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.
  • No diagnosis of a progressive neurological disorder based on previous imaging.
  • 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.
  • Able and willing to swallow whole capsules.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Sacramento, California, 95815, United States

Location

Unknown Facility

Loxahatchee Groves, Florida, 33470, United States

Location

Unknown Facility

Miami, Florida, 33155, United States

Location

Unknown Facility

Wichita, Kansas, 67214, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Hackensack, New Jersey, 07601, United States

Location

Unknown Facility

Akron, Ohio, 4308, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

Norfolk, Virginia, 23510, United States

Location

Unknown Facility

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jennifer Stocks

    Supernus Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

June 2, 2016

Record last verified: 2016-05

Locations

US(10)