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An Open-Label Study to Determine Safety , Tolerability, and Efficacy of Oral Lacosamide in Children With Epilepsy

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00938912
First Posted: July 14, 2009
Last Update Posted: October 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
UCB Pharma
  Purpose
SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy.

Condition Intervention Phase
Epilepsy Drug: Lacosamide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study To Determine Safety, Tolerability And Efficacy Of Long -Term Oral Lacosamide (LCM) As Adjunctive Therapy In Children With Epilepsy

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of subjects who report at least one Treatment-emergent Adverse Event (TEAE) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  • Number of subjects that withdraw due to a Treatment-emergent Adverse Event [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    A TEAE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  • For children 18 months to 5 years, the mean change in Achenbach CBCL/11/2 -5 score from Baseline to end of treatment (Approximately 2 years) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    Achenbach is a validated questionnaire to evaluate a child's competencies and behavioral/emotional problems. Behavioral problems will be scored by the parent(s)/legal representative(s). The version used will depend on the subject's age, The CBCL/1½ 5 checklist is intended for use in children 18 months to 5 years and 11 months of age. For subjects ≥6 years to ≤17 years of age, the CBCL/6 18 version will be used.

  • For children 6 years to 17 years, the mean change in Achenback CBCL/6-18 score from Baseline to end of treatment (Approximately 2 years) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    Achenbach is a validated questionnaire to evaluate a child's competencies and behavioral/emotional problems. Behavioral problems will be scored by the parent(s)/legal representative(s). The version used will depend on the subject's age, The CBCL/1½ 5 checklist is intended for use in children 18 months to 5 years and 11 months of age. For subjects ≥6 years to ≤17 years of age, the CBCL/6 18 version will be used.

  • For children <18 months, the mean change in Bayley III score from Baseline to end of treatment (Approximately 2 years) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    The Bayley III scales are developmental assessment instruments used to examine a young child's development. They measure the developmental functioning of infants and young children from 1 month to 42 months of age. They measure cognitive, language, motor, social-emotional, and adaptive development.

  • For children aged 2 to 4 years, the mean change in BRIEF-P score from Baseline to end of treatment (Approximately 2 years) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    The BRIEF-P includes rating forms used by parents to assess subjects' cognitive skills that are responsible for the planning, initiation, sequencing, and monitoring of complex goal directed behavior.

  • For children aged 5 to 17 years, the mean change in BRIEF score Baseline to end of treatment (Approximately 2 years) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ]
    The BRIEF includes rating forms used by parents to assess subjects' cognitive skills that are responsible for the planning, initiation, sequencing, and monitoring of complex goal directed behavior.

  • Percentage of subjects with a shift in Tanner Scale score from Baseline to End of Treatment [ Time Frame: Visit 9; End of treatment (or early discontinuation visit) ]
    The Tanner Scale is used to evaluate the sexual development of a subject on a scale of 1 to 5. The Tanner Stage will be performed only for subjects who are pubescent at Visit 1 or who enter puberty during the course of the study


Secondary Outcome Measures:
  • Change from Baseline in seizure frequency [ Time Frame: Baseline to visit 9 (approximately 1 year ) ]
  • Change from Baseline in seizure frequency [ Time Frame: Baseline to end of treatment (approximately 2 years) ]
  • Mean Clinical Global Impression of Change score [ Time Frame: Baseline to visit 9 (approximately 1 year) ]
    The Clinical Global Impression of Change is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale.

  • Mean Clinical Global Impression of Change score [ Time Frame: Baseline to end of treatment (approximately 2 years) ]
    The Clinical Global Impression of Change is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale.

  • Mean Caregiver Global Impression of Change score [ Time Frame: Baseline to visit 9 (approximately 1 year) ]
    The Caregiver Global Impression of Change is a 7-point caregiver rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale.

  • Mean Caregiver Global Impression of Change score [ Time Frame: Baseline to end of treatment (approximately 2 years) ]
    The Caregiver Global Impression of Change is a 7-point caregiver rated scale ranging from 1 (very much improved) to 7 (very much worse). Change is defined as a score of 1 (very much improved), 2 (much improved), 3 (a little improved), 4 (no change), 5 (a little worse), 6 (much worse) or 7 (very much worse) on the scale.

  • For children 1 month to 17 years, the mean change in PedsQL health summary score from Baseline to End of treatment (approximately 2 years) [ Time Frame: Baseline to end of treatment (approximately 2 years) ]
    The PedsQL is a validated instrument that consists of generic core scales suitable for use with pediatric populations, including those with acute or chronic health conditions. It is used to evaluate quality of life in the following areas: 1) Physical Functioning/Symptoms, 2) Emotional Functioning, 3) Social Functioning, and 4) Cognitive/School Functioning.

  • LCM Palatability and Ease of Use Questionnaire - Oral Solution [ Time Frame: Visit 9; End of treatment (or early discontinuation visit) ]
    The Palatability and Ease of Use Questionnaire is to assess taste, texture, ease of swallowing of the LCM syrup.

  • LCM Palatability and Ease of Use Questionnaire - Tablets [ Time Frame: Visit 9; End of treatment (or early discontinuation visit) ]
    The Palatability and Ease of Use Questionnaire is to assess taste, texture, ease of swallowing of the LCM tablets.


Estimated Enrollment: 300
Study Start Date: December 2009
Estimated Study Completion Date: May 2022
Estimated Primary Completion Date: May 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide
Subjects and their caregivers may chose to receive Lacosamide oral solution (syrup) or Lacosamide tablets. The maximum duration of LCM administration will be approximately 2 years.
Drug: Lacosamide
Lacosamide oral solution (syrup): Total daily dose between 2 mg/kg/day (1 mg/kg bid) to 12 mg/kg/day (6 mg/kg bid)
Other Name: Vimpat®
Drug: Lacosamide

Lacosamide tablets: Total daily dose between 100 mg (50mg bid) - 600mg (300 mg bid).

The maximum permissible dose of LCM will be 12 mg/kg/day or 600 mg/day.

Other Name: Vimpat®

Detailed Description:

SP848 is an open-label study to evaluate long-term safety, tolerability, and efficacy in children with epilepsy treated with Lacosamide (LCM) oral solution (syrup) or LCM tablets as adjunctive therapy. In addition, the study is designed to provide continued availability of LCM to subjects who have completed the SP847 (NCT00938431) study and to subjects who have discontinued from SP847 (NCT00938431) and who, in the investigator's opinion, would benefit from long-term administration of LCM.

SP848 will be open to subjects who have participated in other LCM pediatric clinical studies in epilepsy and will also be open to up to 100 subjects enrolling directly into SP848. Permissible LCM doses in SP848 are between 2-12 mg/kg/day (oral solution [syrup]) or the corresponding tablet dose up to a maximum dose of 600 mg/day.

Subjects enrolled in SP848 have the option of remaining on the oral solution formulation of LCM or switching to the commercial tablet formulation, if feasible.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A signed informed consent form has been obtained from the parent/legal guardian and assent has been obtained from the subject, as required
  • Subject and caregiver (which may be a parent, legal guardian, or other delegated caregiver) are willing and able to comply with all study requirements, including maintaining a daily seizure diary

Subjects who have participated in SP847 or other lacosamide (LCM) pediatric clinical studies in epilepsy must fulfill the following inclusion criteria:

  • Subject has completed SP847 (or the subject discontinued SP847 due to a dose reduction or status epilepticus) for the treatment of uncontrolled partial-onset seizures, or subject has participated in other LCM pediatric clinical studies in epilepsy
  • Subject is expected to benefit from participation, in the opinion of the investigator

Subjects who enroll directly into SP848 without previous participation in a LCM clinical study must fulfill the following inclusion criteria:

  • Subject is >=4 years to <=17 years of age
  • Subject has a diagnosis of epilepsy with partial-onset seizures
  • Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with at least 2 Antiepileptic Drugs (AEDs) (concurrently or sequentially)
  • Subject has been observed to have at least 2 countable seizures in the 4 week period prior to Screening
  • Subject is on a stable dosage regimen of 1 to 3 AEDs
  • Subject is an acceptable candidate for venipuncture

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
  • Subject >= 6 years of age has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

Subjects who have participated in SP847 or other LCM pediatric clinical studies in epilepsy are not permitted to enroll in the study if any of the following criteria are met:

  • Subject meets either of the following:

    1. Withdrawal criteria for the primary study (with the exception of subjects who discontinued due to a dose reduction or status epilepticus). For subjects entering from EP0060, if the subject (or legal guardian) withdraws consent solely due to route of LCM administration (iv) or if the subject requires more than 10 iv LCM infusions, the subject may be allowed to participant in SP848 after discussion with and agreement from the Medical Monitor
    2. Ongoing serious Adverse Event (SAE)

      Subjects who enroll directly into SP848 without previous participation in a LCM clinical study are not permitted to enroll in the study if any of the following criteria are met:

  • Subject has ever received LCM
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study.
  • Subject has a medical condition that could reasonably be expected to interfere with drug absorption, distribution, metabolism, or excretion
  • Subject has a known hypersensitivity to any component of the investigational medicinal product
  • Subject is a female of childbearing potential and does not practice an acceptable method of contraception for the duration of the study
  • Subject has a creatinine clearance less than 30mL/min
  • Subject has a clinically relevant ECG abnormality, in the opinion of the principal investigator (ie, second or third degree heart block at rest or a QT prolongation greater than 450ms)
  • Subject has hemodynamically significant heart disease (eg, heart failure)
  • Subject has an arrhythmic heart condition requiring medical therapy
  • Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
  • Subject has nonepileptic events, including psychogenic seizures, that could be confused with seizures. If both epileptic and nonepileptic events are present, epileptic events must be distinguished from nonepileptic phenomena
  • Subject has a history of primary generalized epilepsy
  • Subject is taking monoamine oxidase inhibitors-A (MAOI-A) or narcotic analgesics.
  • Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen syndrome
  • Subject has a known sodium channelopathy, such as Brugada syndrome
  • Subject has >2x upper limit of normal (ULN) of any of the following: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or >ULN total bilirubin (1.5xULN total bilirubin if known Gilbert's syndrome). If subject has elevations only in total bilirubin that are >ULN and <1.5xULN, fractionate bilirubin to identify possible undiagnosed Gilbert's syndrome (ie, direct bilirubin <35%)

Subjects who were directly enrolled in EP0060 for iv LCM replacement therapy or to initiate LCM treatment are not permitted to enroll in the study if any of the following criteria are met:

- Subjects have previously participated in a long-term, open-label LCM study

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938912


  Show 57 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Cares +1 844 599 2273(UCB)
  More Information

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00938912     History of Changes
Other Study ID Numbers: SP848
2011-001559-35 ( EudraCT Number )
First Submitted: July 10, 2009
First Posted: July 14, 2009
Last Update Posted: October 27, 2017
Last Verified: October 2017

Keywords provided by UCB Pharma:
Lacosamide (VIMPAT)

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants