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Epilepsies, PartialPhase 1NCT00918047

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

A Phase 1 study testing SPN-804O in people with Epilepsies, Partial, run by Supernus Pharmaceuticals, Inc. at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 4 to 17 years
Conditions the study is for
Epilepsies, Partial
What is being tested?
SPN-804O
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
8 sitesUnited States
Study dates
Jun 2009to Nov 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Previous known hypersensitivity to OXC or other related drugs, such as carbamazepine.
  • Use of an investigational drug or device or participation in an investigational study within 30 days prior to the first dose of SM.
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Study site

    Kingsport, Tennessee

  • Study site

    Lake Success, New York

  • Study site

    Little Rock, Arkansas

  • Study site

    Loxahatchee Groves, Florida

  • Study site

    Rochester, New York

  • Study site

    Rockville, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    Tampa, Florida

Other trials in United States

About this study

Official title: Multiple Dose, Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of OXC XR as Adjunctive Therapy in Pediatric Subjects With Refractory Partial Epilepsy

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

Read the detailed description

This was an open-label, multiple dose, multicenter study consisting of a Screening Period (up to 14 days), a Dosing Period (7 days), and a Follow-up Period (7 days). In-clinic visits occurred at screening, Visit 1 (Day 0), and Visit 2 (Day 7)/Early Discontinuation. All subjects received open-label SPN 804O as adjunctive therapy during the Dosing Period. At Visit 1, eligible subjects were assigned to 1 of 4 treatment groups (150, 300, 450, or 600mg/day) based on weight (15-<30, 30-<45, 45-<60, >=60kg). The Dosing Period consisted of six consecutive days of a daily dose, taken at home, followed by a final day with the dose taken on-site and including blood draws for PK analysis.

Being tested
SPN-804O
Medical subject headings
Epilepsies, Partial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPN-804ODrug

    Also called oxcarbazepine extended-release, OXC XR, Oxtellar XR

    Open Label study

Study groups in NCT00918047
Study groupRoleWhat they receive
SPN-804O 150mg/DayExperimentalSubjects who weighed 15.0 to 29.9 kg dosed with SPN-804O 150mg/Day
Receives: Drug: SPN-804O
SPN-8040 300mg/DayExperimentalSubjects who weighed 30.0 to 44.9 kg dosed with SPN-8040 300mg/Day
Receives: Drug: SPN-804O
SPN-8040 450mg/DayExperimentalSubjects who weighed 45.0 to 59.9 kg dosed with SPN-8040 450mg/Day
Receives: Drug: SPN-804O
SPN-8040 600mg/DayExperimentalSubjects who weighed 60.0 kg and above dosed with SPN-8040 600mg/Day
Receives: Drug: SPN-804O

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionJul 2010
  4. Study completionNov 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00918047
Sponsor's protocol ID
804P107
Status last verified
Jun 2017
First submitted
9 Jun 2009
Last updated
2 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SPN-804O in people with Epilepsies, Partial, run by Supernus Pharmaceuticals, Inc. at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00918047.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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