Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures

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.
 
ClinicalTrials.gov Identifier: NCT01964560
Recruitment Status : Active, not recruiting
First Posted : October 17, 2013
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Tracking Information
First Submitted Date  ICMJE October 14, 2013
First Posted Date  ICMJE October 17, 2013
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE August 2014
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2015)
  • 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) ]
  • 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) ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) during the study [ Time Frame: Baseline to the End of Treatment (approximately 96 weeks) ]
  • Number of subjects reporting at least one Treatment-emergent Adverse Event (TEAE) leading to discontinuation from the study [ Time Frame: Baseline to End of Treatment (approximately 96 weeks) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2013)
  • Percentage of Seizure Free Days at the End of Year 1 [ Time Frame: End of Year 1 of the Study (approximately 52 weeks) ]
  • Percentage of Seizure Free Days at the End of Year 2 [ Time Frame: End of Year 2 of the Study (approximately 96 weeks) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures
Official Title  ICMJE 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
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.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Epilepsy
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Drug: Lacosamide
  • Drug: Lacosamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 23, 2020)
540
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2013)
500
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Bulgaria,   China,   Colombia,   Croatia,   Czechia,   Estonia,   France,   Georgia,   Greece,   Hungary,   Israel,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Moldova, Republic of,   Montenegro,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Serbia,   Slovakia,   Slovenia,   Taiwan,   Thailand,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01964560
Other Study ID Numbers  ICMJE EP0034
2012-005012-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma ( UCB BIOSCIENCES, Inc. )
Study Sponsor  ICMJE UCB BIOSCIENCES, Inc.
Collaborators  ICMJE PRA Health Sciences
Investigators  ICMJE
Study Director: UCB Cares +1 844 599 2273
PRS Account UCB Pharma
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP