Study of PK and Safety of OXC (Oxcarbazepine) XR (Extended Release) as Adjunctive Therapy in Pediatric Epilepsy Patients

NCT00918047 | Completed Phase 1

• 1 other identifier: 804P107
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

Brief Summary

Study to evaluate the pharmacokinetics, safety, and tolerability of OXC XR as adjunctive therapy in pediatric subjects with refractory partial epilepsy.

Conditions

Epilepsies, Partial

Outcome Measures

Primary Outcomes (1)

• Examine the steady-state pharmacokinetics (PK) of OXC XR and to assess the safety and tolerability of repeated oral dosing of OXC XR in pediatric subjects with partial seizures.

Study Arms (4)

SPN-804O 150mg/Day

EXPERIMENTAL

Subjects who weighed 15.0 to 29.9 kg dosed with SPN-804O 150mg/Day

Drug: SPN-804O

SPN-8040 300mg/Day

EXPERIMENTAL

Subjects who weighed 30.0 to 44.9 kg dosed with SPN-8040 300mg/Day

Drug: SPN-804O

SPN-8040 450mg/Day

EXPERIMENTAL

Subjects who weighed 45.0 to 59.9 kg dosed with SPN-8040 450mg/Day

Drug: SPN-804O

SPN-8040 600mg/Day

EXPERIMENTAL

Subjects who weighed 60.0 kg and above dosed with SPN-8040 600mg/Day

Drug: SPN-804O

Interventions

SPN-804O DRUG

Open Label study

Also known as: oxcarbazepine extended-release, OXC XR, Oxtellar XR

SPN-8040 300mg/Day; SPN-8040 450mg/Day; SPN-8040 600mg/Day; SPN-804O 150mg/Day

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Able to provide written informed assent (IAF), as appropriate, with written informed permission (and informed consent (ICF) where required by regional laws or regulations) from the parent or legally-authorized representative (LAR).
• Male or female aged 4 to 17 years, inclusive, with a current diagnosis of partial onset seizures with or without secondarily generalized seizures as confirmed by the 1981 and 1989 International League Against Epilepsy Classifications).
• Currently receiving treatment with at least one and up to two anti-epileptic drugs (AEDs), excluding oxcarbazepine and phenytoin. AED therapy 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. A vagal nerve stimulator implanted for at least six months and with parameters unchanged for at least one month prior to Visit 1 is allowed and not considered to be an AED. Magnet use is allowed.
• No diagnosis of a progressive neurological disorder based on previous imaging.
• Weight within the 25 - 75 % 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 tablets.
• Females of childbearing potential (FOCP) should either be sexually inactive (abstinent) for 14 days prior to the first dose, throughout the study and for four days following the last dose or, if sexually active, will be using one of the following acceptable birth control methods:
• Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six months minimum;
• Intrauterine device in place for at least three months;
• Barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for four days following the last dose;
• Surgical sterilization of the partner (vasectomy for six months minimum);
• Hormonal contraceptives in addition to a barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose, throughout the study and for four days following the last dose.

You may not qualify if:

• A documented history of status epilepticus in the past year.
• Seizures secondary to illicit drug or alcohol use, infection, neoplasia, demyelinating disease, degenerative neurological disease, or central nervous system disease deemed progressive, metabolic illness, or progressive degenerative disease.
• Diagnosis or an electroencephalogram consistent with a diagnosis of seizure disorders other than partial epilepsy.
• Meets criteria for history of major depressive or manic episode, according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision.
• Any history of suicide intent and/or attempt.
• History or presence of clinically significant, chronic medical condition, especially those contraindicating antiseizure medication, (e.g., any neurological, gastrointestinal, endocrine, cardiovascular, pulmonary, hematological, immunologic, renal, hepatic or metabolic disease) that may affect the safety of the subject in the opinion of the Investigator.
• Use of oxcarbazepine or phenytoin within 10 days prior to first dose of SM.
• Use of felbamate with less than 18 months of continuous exposure prior to screening.
• Frequent need of rescue benzodiazepines (more than once in a 28 day period).
• Use of diuretics or other sodium-lowering medications within seven days prior to first dose of study medication (SM).
• History or presence of clinically significant laboratory, electrocardiogram (ECG), or vital sign abnormalities at screening that may affect the safety of the subject, in the opinion of the Investigator.
• Presence of potential hepatic function impairment as shown by, but not limited to, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times the upper limit of normal (ULN), or total bilirubin \>1.5 times ULN.
• Presence of suspected impairment of renal function defined by serum creatinine ≥1.5 times ULN.
• History of substance abuse or dependence.
• Females who are pregnant or lactating.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (8)

Unknown Facility

Little Rock, Arkansas, United States

Location

Unknown Facility

Loxahatchee Groves, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Rockville, Maryland, United States

Location

Unknown Facility

Lake Success, New York, United States

Location

Unknown Facility

Rochester, New York, United States

Location

Unknown Facility

Kingsport, Tennessee, United States

Location

Unknown Facility

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Oxcarbazepine

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Carbamazepine; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: June 9, 2009
• First Posted: June 11, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 2, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)