Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by UCB, Inc.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT01921205
First received: August 8, 2013
Last updated: July 23, 2014
Last verified: July 2014
  Purpose

Study to evaluate the efficacy of Lacosamide (LCM) administered in addition to 1 to ≤3 other Anti-Epileptic Drugs in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.


Condition Intervention Phase
Epilepsy
Drug: Lacosamide
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Double Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects With Epilepsy ≥4 Years to <17 Years of Age With Partial Onset Seizures

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • Change in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of responders, ≥ 50% reduction in partial onset seizure frequency from Baseline to the Maintenance Period [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
    Proportion of responders, where a responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency from Baseline to the Maintenance Period.

  • Proportion of subjects experiencing a ≥25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency from Baseline to the end of Maintenance Period [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
  • Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing a ≥25 % to <50 %, 50 % to 75 %, or >75 % reduction in partial onset seizure frequency from Baseline to the entire treatment (ie, Titration+Maintenance Periods) [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing no change in partial onset seizure frequency (between <25 % reduction and <25 % increase) from Baseline to the entire treatment (ie, Titration+Maintenance Periods) [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
  • Proportion of subjects experiencing an increase in partial onset seizure frequency of ≥25 % from Baseline to the entire treatment (ie, Titration+Maintenance Periods) [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
  • Change in partial onset seizure frequency per 28 days from Baseline to the entire treatment (ie, Titration+Maintenance Periods) by seizure type [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]
  • Proportion of seizure free days during the Maintenance Period for subjects who completed the Maintenance Period [ Time Frame: Week 7 to Week 16 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieved "seizure free" status (yes/no) for subjects who completed the Maintenance Period [ Time Frame: Baseline to Week 16 (or last value on treatment) ] [ Designated as safety issue: No ]

Estimated Enrollment: 308
Study Start Date: August 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacosamide Drug: Lacosamide

Subjects <30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day)

Subjects ≥30 kg to <50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)

Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)

Other Name: Vimpat(R)
Placebo Comparator: Placebo Other: Placebo

Subjects <30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day)

Subjects ≥30 kg to <50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)

Subjects ≥50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)


Detailed Description:

The primary objective of this study is to evaluate the efficacy of LCM administered concomitantly with 1 to ≤3 Anti-Epileptic Drugs (AEDs) in subjects with epilepsy ≥4 years to <17 years of age who currently have uncontrolled partial onset seizures.

The secondary objective is to evaluate the safety and tolerability of LCM in subjects ≥4 years to <17 years of age.

An additional objective is to evaluate the pharmacokinetics (PK) of LCM in subjects ≥4 years to <17 years of age.

  Eligibility

Ages Eligible for Study:   4 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • An Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent form is signed and dated by the parent(s) or legal representative. The Informed Consent form or a specific Assent form, where required, will be signed and dated by minors
  • 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 from ≥4 years to <17 years of age
  • Subject has a diagnosis of Epilepsy with partial-onset seizures. The results of ≥1 prior electroencephalogram (EEG) AND 1 prior magnetic resonance imaging/computerized tomography scan should be consistent with the above diagnosis
  • Subject has been observed to have uncontrolled partial-onset seizures after an adequate course of treatment (in the opinion of the investigator) with ≥2 Anti-Epileptic Drugs (AEDs) (concurrently or sequentially)
  • Subject must have been observed to have on average ≥2 partial onset seizures per 28 days with seizure free phase no longer than 21 days in the 8 week period prior to entry into the Baseline Period. During this study, subjects must have reported ≥2 partial onset seizures during the 8 week prospective Baseline Period to be eligible for randomization at Visit 2. (Note: In the case of simple partial onset seizures, only those seizures with motor signs will be counted towards meeting the inclusion criterion.)
  • Subject is on a stable dosage regimen of 1 to ≤3 AEDs. The daily dosage regimen of concomitant AED therapy must be kept constant for a period of ≥4 weeks prior to the Baseline Period
  • Vagal nerve stimulation (VNS) is allowed and will not be counted as a concomitant AED. The VNS device must be implanted for ≥6 months before Visit 1, and the device settings must be stable for ≥4 weeks before Visit 1 and be kept stable during the Baseline Period. Use of the VNS device magnet is allowed

Exclusion Criteria:

  • Subject has previously participated in this study or subject has been assigned to Lacosamide (LCM) in a previous LCM study
  • Subject has participated in another study of an investigational medicinal product (IMP) or a medical device within ≤2 months of Visit 1 or is currently participating in another study of an IMP or a medical device
  • Subject has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the subject's ability to participate in this study
  • Subject ≥6 years of age 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 Screening
  • Subject has a known hypersensitivity to any component of the IMP or has ever received LCM
  • 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 (according to International Conference on Harmonisation [ICH] guidance defined as those that result in a failure rate of less than 1% per year when used consistently and correctly), unless sexually abstinent, for the duration of the study. Female subject of childbearing potential taking enzyme inducing antiepileptic drugs (EI AEDs: carbamazepine, phenytoin, barbiturates, primidone, topiramate, oxcarbazepine) who is not surgically sterile or does not practice 1 highly effective method of contraception according to the WHO recommendation (ie, depot medroxyprogesterone acetate, norethisterone enantate, intrauterine devices, combined injectables, and progestogen implants) with administration of EI AEDs OR does not practice 2 combined methods of contraception (ie, combined hormonal contraception plus barrier method with spermicidal agent), unless sexually abstinent, for the duration of the study
  • Subject has a medical condition that could be expected in the opinion of the investigator to interfere with drug absorption, distribution, metabolism, or excretion
  • Subject has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary
  • Subject is on a ketogenic or other specialized diet. If the subject was on a specialized diet in the past, they must be off the diet for ≥2 months prior to the Baseline Period
  • Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin level ≥2 times the upper limit of normal (ULN), or creatinine clearance less than 50 mL/min
  • Subject has a clinically relevant ECG abnormality, in the opinion of the investigator (eg, second or third degree heart block at rest or a corrected QT interval [QTc] greater than 450 ms)
  • Subject has hemodynamically significant congenital heart disease
  • Subject has an arrhythmic heart condition requiring medical therapy
  • Subject has a known history of severe anaphylactic reaction or serious blood dyscrasias
  • Subject has nonepileptic events that could be confused with seizures
  • Subject has a current diagnosis of Lennox-Gastaut syndrome, primary generalized epilepsy, mixed seizure disorder (partial and primarily generalized seizures), or purely nocturnal seizures
  • Subject has a history of convulsive status epilepticus ≤2 months prior to the Baseline Period
  • Subject has been treated with vigabatrin and experienced any vision loss. Subjects who have received vigabatrin in the past must have documentation of an assessment for vision loss prior to study entry or documentation of why visual field testing cannot be performed
  • Subject has been treated with felbamate and has experienced any serious toxicity issues (defined as liver failure, aplastic anemia) with this treatment. Subjects treated with felbamate for <12 months are excluded. Note: any subject who has been treated with felbamate for ≥12 months and has not experienced serious toxicity issues is eligible
  • Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease, such as Rasmussen syndrome
  • Subject has a medically documented history of alcohol or drug abuse
  • Subject has a known sodium channelopathy, such as Brugada syndrome
  • Subject has an acute or sub acutely progressive central nervous system disease. Subject has epilepsy secondary to a progressing cerebral disease or any other progressively neurodegenerative disease (malignant brain tumor or Rasmussen Syndrome)
  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: NCT01921205

Contacts
Contact: UCB Call Center 1 877 822 9493

  Show 52 Study Locations
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center 1 877 822 9493
  More Information

No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT01921205     History of Changes
Other Study ID Numbers: SP0969, 2012-004996-38
Study First Received: August 8, 2013
Last Updated: July 23, 2014
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Colombia: Ministry of Health and Social Protection
Belgium: Federal Agency for Medicinal Products and Health Products
France: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health
Spain: Ministry of Health
Switzerland: Federal Office of Public Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Israel: Ministry of Health
Czech Republic: State Institute for Drug Control
Hungary: Ministry of Health, Social and Family Affairs
Poland: Ministry of Health
Bulgaria: Ministry of Health
Turkey: Ministry of Health
Estonia: The State Agency of Medicine
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Serbia: Medicines and Medical Devices Agency
Thailand: Research Institute for Health Sciences
Japan: Pharmaceuticals and Medical Devices Agency
Taiwan : Food and Drug Administration
Korea: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by UCB, Inc.:
Lacosamide
Vimpat
UCB
Epilepsy
Partial Onset Seizures
Pediatric

Additional relevant MeSH terms:
Epilepsy
Central Nervous System Diseases
Nervous System Diseases
Seizures
Brain Diseases
Neurologic Manifestations
Signs and Symptoms
Lacosamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014