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

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

Tracking Information

• First Submitted Date: October 14, 2013
• First Posted Date: October 17, 2013
• Last Update Posted Date: August 14, 2020
• Actual Study Start Date: August 2014
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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) ]

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Long-term Extension Study to Investigate Lacosamide as an Add-on Therapy in Children With Partial Onset Seizures
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: June 23, 2020): 540
• Original Estimated Enrollment (submitted: October 14, 2013): 500
• Estimated Study Completion Date: April 2022
• Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT01964560
• Other Study ID Numbers: EP0034; 2012-005012-26 ( EudraCT Number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
• Study Sponsor: UCB BIOSCIENCES, Inc.
• Collaborators: PRA Health Sciences

Investigators

• Study Director: UCB Cares; +1 844 599 2273

• PRS Account: UCB Pharma
• Verification Date: August 2020