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:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00938912
First received: July 10, 2009
Last updated: April 24, 2013
Last verified: April 2013
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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:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
Drug Information available for:
Lacosamide
U.S. FDA Resources
Further study details as provided by UCB, Inc.:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938912
Locations
| United States, California | |
| 025 | |
| Sacramento, California, United States | |
| United States, District of Columbia | |
| 002 | |
| Washington, District of Columbia, United States | |
| United States, Florida | |
| 012 | |
| Tampa, Florida, United States | |
| 019 | |
| Wellington, Florida, United States | |
| United States, Minnesota | |
| 006 | |
| St. Paul, Minnesota, United States | |
| United States, Missouri | |
| 008 | |
| Kansas City, Missouri, United States | |
| United States, New Jersey | |
| 015 | |
| New Brunswick, New Jersey, United States | |
| United States, North Carolina | |
| 005 | |
| Durham, North Carolina, United States | |
| United States, Pennsylvania | |
| 001 | |
| Philadelphia, Pennsylvania, United States | |
| 016 | |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| 004 | |
| Nashville, Tennessee, United States | |
| United States, Texas | |
| 026 | |
| Austin, Texas, United States | |
| 022 | |
| Houston, Texas, United States | |
| United States, Virginia | |
| 020 | |
| Norfolk, Virginia, United States | |
| Belgium | |
| 201 | |
| Brussels, Belgium | |
| 200 | |
| Edegem, Belgium | |
| 203 | |
| Gent, Belgium | |
| 202 | |
| Leuven, Belgium | |
| Mexico | |
| 106 | |
| Aguascalientes, Mexico | |
| 101 | |
| Culiacan, Mexico | |
| 104 | |
| Guadalajara, Mexico | |
| 105 | |
| Monterrey, Mexico | |
| 103 | |
| San Luis Potosi, Mexico | |
Sponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00938912 History of Changes |
| Other Study ID Numbers: | SP848 |
| Study First Received: | July 10, 2009 |
| Last Updated: | April 24, 2013 |
| Health Authority: | United States: Food and Drug Administration Mexico: Ministry of Health Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by UCB, Inc.:
|
Lacosamide (VIMPAT) |
Additional relevant MeSH terms:
|
Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013