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:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00938912
First received: July 10, 2009
Last updated: August 25, 2014
Last verified: August 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 Bailey III score from Baseline to end of treatment (Approximately 2 years) [ Time Frame: Baseline to end of treatment (Approximately 2 years) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change from Baseline in seizure frequency [ Time Frame: Baseline to visit 9 (approximately 1 year ) ] [ Designated as safety issue: No ]
  • Change from Baseline in seizure frequency [ Time Frame: Baseline to end of treatment (approximately 2 years) ] [ Designated as safety issue: No ]
  • Mean Clinical Global Impression of Change score [ Time Frame: Baseline to visit 9 (approximately 1 year) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    The Palatability and Ease of Use Questionnaire is to assess taste, texture, ease of swallowing of the LCM tablets.


Estimated Enrollment: 192
Study Start Date: December 2009
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (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) - 60 0mg (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 2, 4, 6, 8, 10, and 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

Ages Eligible for Study:   1 Month to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All subjects in SP848 must fulfill the following 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 is expected to benefit from participation, in the opinion of the investigator
  • 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 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

Subjects who enroll directly into SP848 without previous participation in a Lacosamide (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 meets the withdrawal criteria for the primary study (SP847) (with the exception of subjects who discontinued due to a dose reduction or status epilepticus), or is experiencing an ongoing Adverse Event (AE) or Serious Adverse Event (SAE)
  • Subject has a lifetime history of suicide attempt, or has suicidal ideation in the past 6 months

For subjects who enroll directly into SP848 :

  • Subject has ever received LCM
  • Subject has a known hypersensitivity to any component of the investigational medicinal product
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938912

  Show 43 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00938912     History of Changes
Other Study ID Numbers: SP848, 2011-001559-35
Study First Received: July 10, 2009
Last Updated: August 25, 2014
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy

Keywords provided by UCB Pharma:
Lacosamide (VIMPAT)

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014