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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01921205
Other study ID # SP0969
Secondary ID 2012-004996-38
Status Completed
Phase Phase 3
First received
Last updated
Start date August 29, 2013
Est. completion date January 24, 2017

Study information

Verified date March 2018
Source UCB Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 404
Est. completion date January 24, 2017
Est. primary completion date January 24, 2017
Accepts healthy volunteers No
Gender All
Age group 4 Years to 16 Years
Eligibility 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 30 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 a medically documented history of alcohol or drug abuse

- Subject has a known cardiac 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)

Study Design


Related Conditions & MeSH terms


Intervention

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:
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)

Locations

Country Name City State
Argentina 143 Buenos Aires
Argentina 142 Cordoba
Australia 200 Heidelberg West
Australia 203 Herston
Australia 205 South Brisbane
Belgium 304 Brussels
Bulgaria 310 Sofia
Bulgaria 312 Sofia
Colombia 172 Floridablanca
Colombia 171 Medellin
Croatia 613 Osijek
Croatia 610 Rijeka
Croatia 612 Zagreb
Czechia 321 Hradec Kralove
Czechia 320 Ostrava-Poruba
Czechia 322 Praha 4
Czechia 323 Praha 5
Estonia 331 Tallinn
Estonia 330 Tartu
Georgia 620 Tbilisi
Georgia 621 Tbilisi
Georgia 622 Tbilisi
Georgia 623 Tbilisi
Hungary 361 Budapest
Hungary 362 Budapest
Hungary 363 Budapest
Hungary 364 Budapest
Hungary 360 Debrecen
Hungary 367 Miskolc
Hungary 366 Pecs
Israel 370 Holon
Israel 371 Kfar Saba
Israel 374 Petach Tikva
Israel 372 Tel Aviv
Italy 384 Bologna
Italy 388 Florence
Italy 387 Genova
Italy 380 Mantova
Italy 381 Milano
Italy 393 Padova
Italy 383 Roma
Italy 392 Roma
Italy 386 Verona
Korea, Republic of 211 Daegu
Korea, Republic of 210 Seoul
Korea, Republic of 212 Seoul
Korea, Republic of 213 Seoul
Korea, Republic of 215 Seoul
Latvia 400 Riga
Latvia 402 Valmiera
Lithuania 411 Kaunas
Mexico 569 Culiacan
Mexico 563 Guadalajara
Mexico 568 Monterrey
Montenegro 660 Podgorica
Poland 433 Gdansk
Poland 432 Katowice
Poland 420 Kielce
Poland 422 Krakow
Poland 431 Krakow
Poland 423 Poznan
Poland 425 Poznan
Poland 421 Szczecin
Poland 429 Tyniec Maly
Poland 430 Warszawa
Poland 428 Wroclaw
Romania 574 Bucuresti
Romania 572 Cluj-Napoca
Romania 576 Sibiu
Romania 580 Suceava
Romania 570 Timisoara
Romania 577 Timisoara
Russian Federation 443 Kazan
Russian Federation 444 Kazan
Russian Federation 442 Moscow
Russian Federation 449 Moscow
Russian Federation 440 Smolensk
Russian Federation 441 St. Petersburg
Russian Federation 446 St. Petersburg
Russian Federation 447 Voronezh
Serbia 464 Belgrade
Serbia 460 Kragujevac
Serbia 461 Novi Beograd
Serbia 462 Novi Sad
Serbia 463 Novi Sad
Slovakia 470 Bardejov
Slovakia 473 Nitra
Slovakia 472 Nove Zamky
Slovenia 670 Ljubljana
Taiwan 220 Changhua
Taiwan 222 Taichung
Taiwan 224 Taipei
Thailand 232 Bangkok
Thailand 236 Bangkoknoi
Thailand 231 Muang
Thailand 233 Muang
Thailand 235 Pathumwan
Thailand 230 Ratchathewi
Ukraine 602 Dnipropetrovsk
Ukraine 606 Kiev
Ukraine 682 Uzhgorod
Ukraine 603 Vinnitsa
United Kingdom 514 Birmingham
United Kingdom 515 Birmingham
United Kingdom 511 Leeds
United States 103 Atlanta Georgia
United States 127 Boulder Colorado
United States 102 Charlotte North Carolina
United States 122 Dallas Texas
United States 640 Eugene Oregon
United States 115 Las Vegas Nevada
United States 124 Lexington Kentucky
United States 112 Louisville Kentucky
United States 105 Orlando Florida
United States 114 Seattle Washington
United States 121 Shreveport Louisiana
United States 117 Tampa Florida
United States 101 Tomball Texas

Sponsors (1)

Lead Sponsor Collaborator
UCB Pharma

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Belgium,  Bulgaria,  Colombia,  Croatia,  Czechia,  Estonia,  Georgia,  Hungary,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Mexico,  Montenegro,  Poland,  Romania,  Russian Federation,  Serbia,  Slovakia,  Slovenia,  Taiwan,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Partial Onset Seizure (POS) Frequency Per 28 Days From Baseline to the Maintenance Period The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. Baseline to Week 16 (or last value on treatment)
Secondary Proportion of Responders Where a Responder is Defined as a Participant With >= 50% Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Maintenance Period Proportion of responders is presented as percentage of participants. A responder is a subject experiencing a 50 % or greater reduction in partial onset seizure frequency per 28 days from Baseline to the Maintenance Period. Baseline to Week 16 (or last value on treatment)
Secondary Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the End of Maintenance Period Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Maintenance Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A >=50%-<=75% response in the Maintenance Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. A 75% response in the Maintenance Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Maintenance Period. Baseline to Week 16 (or last value on treatment)
Secondary Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. Baseline to Week 16 (or last value on treatment)
Secondary Proportion of Subjects Experiencing a >=25 % to <50 %, 50 % to 75 %, or >75 % Reduction in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) Proportion of subjects is presented as percentage of participants. A >=25%-<50% response in the Treatment Period is defined as >=25% to <50% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A >=50%-<=75% response in the Treatment Period is defined as >=50% to <=75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. A 75% response in the Treatment Period is defined as >75% reduction in POS frequency per 28 days from Baseline to end of Treatment Period. Baseline to Week 16 (or last value on treatment)
Secondary Proportion of Subjects Experiencing no Change in Partial Onset Seizure Frequency (Between <25 % Reduction and <25 % Increase) Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) Proportion of subjects is presented as percentage of participants. No change is defined as between <25% reduction and <25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise not between <25% reduction and <25% increase is defined as a change. Baseline to Week 16 (or last value on treatment)
Secondary Proportion of Subjects Experiencing an Increase in Partial Onset Seizure Frequency Per 28 Days of >=25 % From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) Proportion of subjects is presented as percentage of participants. An increase is defined as a >=25% increase in POS frequency per 28 days from Baseline to the entire Treatment Period, otherwise <25% increase is defined as no increase. Baseline to Week 16 (or last value on treatment)
Secondary Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Simple Partial Seizures The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. Baseline to Week 16 (or last value on treatment)
Secondary Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Complex Partial Seizures The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. Baseline to Week 16 (or last value on treatment)
Secondary Change in Partial Onset Seizure Frequency Per 28 Days From Baseline to the Entire Treatment (ie, Titration+Maintenance Periods) for Secondary Generalized Seizures The POS frequency is standardized to a 28-day duration. Negative values indicate improvement from Baseline. Baseline to Week 16 (or last value on treatment)
Secondary Proportion of Seizure Free Days During the Maintenance Period for Subjects Who Completed the Maintenance Period The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded. Week 7 to Week 16
Secondary Proportion of Subjects Who Achieved "Seizure Free" Status (Yes/no) for Subjects Who Completed the Maintenance Period The proportion of seizure free days is calculated as (days with number of seizures = 0) divided by (days with recorded data in the subject diary), where 'days with recorded data in the subject diary' excludes any days where 'Not Done' is recorded. Week 7 to Week 16
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