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Trial record 1 of 2 for:    NCT01964560
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Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures

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ClinicalTrials.gov Identifier: NCT01964560
Recruitment Status : Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : November 6, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Brief Summary:
Study to evaluate the long-term safety and tolerability of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥1 month to ≤18 years who currently have uncontrolled partial onset seizures.

Condition or disease Intervention/treatment Phase
Epilepsy Drug: Lacosamide Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Detailed Description:

The primary objective of this study is to evaluate the long-term safety and tolerability of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥1 month to ≤18 years of age who currently have uncontrolled partial onset seizures.

The secondary objective is to evaluate the efficacy during long-term exposure to LCM in subjects epilepsy ≥1 month to ≤18 years of age.

An additional objective is to assess behavior, cognition, quality of life, and development during long-term LCM exposure in pediatric subjects

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 540 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Long-term Extension Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Pediatric Subjects With Epilepsy With Partial-Onset Seizures
Actual Study Start Date : August 2014
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
Drug Information available for: Lacosamide

Arm Intervention/treatment
Experimental: Lacosamide

In the first week after enrollment into EP0034 subjects will be dosed according to their weight:

  • Lacosamide (LCM) 10 mg/kg/day (oral solution) for subjects weighing <30 kg
  • LCM 6 mg/kg/day (oral solution) for subjects weighing ≥30 kg to <50 kg
  • LCM 300 mg/day (tablets) for subjects weighing ≥50 kg

After 1 week the investigator may adjust the LCM dose during the Treatment Period based on clinical judgment within a range of 2 mg/kg/day to 12 mg/kg/day for the oral solution and 100 mg/day to 600 mg/day for the tablets.

Drug: Lacosamide

Pharmaceutical form: oral solution

Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)

Route of administration: oral use

Other Name: VIMPAT

Drug: Lacosamide

Pharmaceutical form: tablet

Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)

Route of administration: oral use

Other Name: VIMPAT




Primary Outcome Measures :
  1. Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study (TEAE) during the study [ Time Frame: Week 0 to the End of Treatment (approximately 96 weeks) ]
  2. Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study [ Time Frame: Week 0 to End of Treatment (approximately 96 weeks) ]

Secondary Outcome Measures :
  1. Percentage of Seizure Free Days at the End of Year 1 [ Time Frame: End of Year 1 of the Study (approximately 52 weeks) ]
  2. Percentage of Seizure Free Days at the End of Year 2 [ Time Frame: End of Year 2 of the Study (approximately 96 weeks) ]


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.


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

Inclusion Criteria:

  • An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form (ICF) is signed and dated by the subject or legal representative. The ICF or a specific Assent form, where required, will be signed and dated by minors
  • Subject has completed the Transition Period of SP0967 or SP0969 (NCT01921205) for the treatment of uncontrolled partial-onset seizures in pediatric epilepsy
  • Subject is expected to benefit from participation, in the opinion of the investigator
  • Subject/legal representative is considered reliable and capable of adhering to the protocol (eg, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the investigator
  • Subject is male or female aged 1 month to ≤17 years.
  • Subject has a diagnosis of epilepsy with partial onset seizures.

Exclusion Criteria:

  • Subject is receiving any investigational drugs or using any experimental devices in addition to Lacosamide (LCM)
  • Subject meets a mandatory withdrawal criterion (ie, MUST withdraw criterion) for SP0967 or SP0969, or is experiencing an ongoing Serious Adverse Event (SAE)
  • For subjects ≥6 years of age, subject has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ("Yes") to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1
  • Female subject who is pregnant or nursing, and/or a female subject of childbearing potential who is not surgically sterile or does not practice 1 highly effective method of contraception

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): NCT01964560


Locations
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Sponsors and Collaborators
UCB BIOSCIENCES, Inc.
PRA Health Sciences
Investigators
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Study Director: UCB Cares +1 844 599 2273
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Responsible Party: UCB BIOSCIENCES, Inc.
ClinicalTrials.gov Identifier: NCT01964560    
Other Study ID Numbers: EP0034
2012-005012-26 ( EudraCT Number )
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Keywords provided by UCB Pharma ( UCB BIOSCIENCES, Inc. ):
Lacosamide
Vimpat
UCB
Epilepsy
Partial Onset Seizures
Pediatric
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Lacosamide
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action