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Trial record 1 of 1 for:    NCT02124564
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A Trial to Evaluate the Long Term Safety and Tolerability of Lacosamide Taken as Monotherapy in Adults With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT02124564
Recruitment Status : Completed
First Posted : April 28, 2014
Results First Posted : June 28, 2019
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Epilepsy
Partial-onset Seizures
Intervention Drug: Lacosamide
Enrollment 19
Recruitment Details The study started to enroll patients in April 2014 and concluded in November 2017.
Pre-assignment Details Participant flow refers to Safety Set including all subjects which took at least one dose of study medication.
Arm/Group Title Lacosamide
Hide Arm/Group Description Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
Period Title: Treatment Period
Started 19
Started Treatment Period 19
Started Titration Period 19
Started AED Withdrawal Period 19
Started Monotherapy Period 17
Started Evaluation Period 17
Started Follow-Up Period 13
Completed 12
Not Completed 7
Reason Not Completed
Adverse Event             2
Lack of Efficacy             3
Withdrawal by Subject             2
Period Title: Taper Period
Started [1] 2
Completed 2
Not Completed 0
[1]
Subjects receiving LCM >200mg/day at the End-of-Study/Early Withdrawal Visit should be tapered off.
Arm/Group Title Lacosamide
Hide Arm/Group Description Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
The Baseline Characteristics refer to the Safety Analysis Set which included all subjects who took at least 1 dose of study drug.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
<=18 years
0
   0.0%
Between 18 and 65 years
17
  89.5%
>=65 years
2
  10.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
39.2  (15.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
8
  42.1%
Male
11
  57.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Asian (Japanese)
19
 100.0%
Other
0
   0.0%
1.Primary Outcome
Title Number of Subjects With at Least One Incidence of Treatment-Emergent Adverse Events (TEAEs) During the Study
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacosamide (Safety Set)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 g/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
19
 100.0%
2.Primary Outcome
Title Number of Subjects Who Withdraw Due to Adverse Events (AEs) During the Study
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time Frame From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacosamide (Safety Set)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 g/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.5%
3.Primary Outcome
Title Number of Subjects With at Least One Incidence of Serious Adverse Events (SAEs) During the Study
Hide Description

A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly or birth defect
  • Is as infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above
Time Frame From the Titration Period (investigational product is taken) to the End of Study Visit (up to 3.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacosamide (Safety Set)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 g/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
2
  10.5%
4.Secondary Outcome
Title Number of Subjects Remaining Seizure Free for 6 Consecutive Months During the Monotherapy Period
Hide Description

Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.

A subject was considered seizure free, if no seizure occurred during the 6 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:

  • A documented seizure during 6 consecutive months of the Evaluation Analysis Period
  • Subject discontinued the study prematurely during the Evaluation Analysis Period
  • Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period
Time Frame From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of subjects in the Safety Set (SS) who had at least 1 seizure diary assessment. Subjects who discontinued before the end date of 6 consecutive months were included in this analysis.
Arm/Group Title Lacosamide (FAS)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
6
  46.2%
5.Secondary Outcome
Title Number of Subjects Remaining Seizure Free for 12 Consecutive Months During the Monotherapy Period
Hide Description

Subjects were considered seizure free if their seizure counts for every day over the entire Treatment Period was zero and if they completed the Treatment Period.

A subject was considered seizure free, if no seizure occurred during the 12 consecutive months in the Evaluation Period. If one of the following occurred, the subject was not considered seizure free:

  • A documented seizure during 6 consecutive months of the Evaluation Analysis Period
  • Subject discontinued the study prematurely during the Evaluation Analysis Period
  • Missing Seizure Count Case Report Forms (CRFs) prior to completing the Evaluation Analysis Period.

Subjects who discontinued before the end date of 6 consecutive months were included in this analysis.

Time Frame From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of subjects in the SS who had at least 1 seizure diary assessment. Subjects who discontinued before the end date of 12 consecutive months were included in this Analysis.
Arm/Group Title Lacosamide (FAS)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
6
  46.2%
6.Secondary Outcome
Title Percentage of Participants in the Monotherapy Period Without Discontinuation Due to Adverse Events (AE) or Lack of Efficacy (LOE)
Hide Description For Time to discontinuation (event), Retention rate and 95% CI was calculated using the Kaplan-Meier method. Retention rate is indicated in Percent and 95% confidence intervals (CI) with respect to the Time to discontinuation.
Time Frame From the beginning of the Monotherapy Period to the end of the Follow-Up Period (up to 3.1 years until the time of approval granted)
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) consisted of subjects in the Safety Set (SS) who had at least 1 seizure diary assessment. Subjects who discontinued before Monotherapy Period were not included in this Analysis.
Arm/Group Title Lacosamide (FAS)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 17
Median (95% Confidence Interval)
Unit of Measure: Percentage of participant
Retention Rate after 6-months
81.3
(52.46 to 93.54)
Retention Rate after 12-months
81.3
(52.46 to 93.54)
Retention Rate after 18-months
81.3
(52.46 to 93.54)
Retention Rate after 24-months
81.3
(52.46 to 93.54)
7.Secondary Outcome
Title Plasma Concentrations of Lacosamide Versus Time Postdose
Hide Description Dose-normalized lacosamide Plasma Concentration (µg/mL) by Visit and Dose during the Evaluation Period.
Time Frame From Titration Period up to Week 94
Hide Outcome Measure Data
Hide Analysis Population Description
Two Subjects withdrew during the AED Withdrawal Period (prior to the Evaluation Period).
Arm/Group Title Lacosamide (Safety Set)
Hide Arm/Group Description:
Subjects randomized in this arm received lacosamide from 200 mg/day to 600 g/day, from the Titration to the End of Study Visit (up to 3.5 years).
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: µg/mL
Concentration at First Visit 0.028  (0.016)
Concentration at Last Visit 0.034  (0.010)
Time Frame Adverse Events were collected from Visit 1 until Safety Follow-Up Visit (up to week 2 after last dose), for approximately 3.5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description Subjects randomized in this arm received lacosamide from 200 mg/day to 600 mg/day, from the Titration to the End of Study Visit (up to 3.5 years).
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   0/19 (0.00%)    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   2/19 (10.53%)    
Nervous system disorders   
Convulsion * 1  1/19 (5.26%)  1
Vascular disorders   
Varicose vein * 1  1/19 (5.26%)  2
1
Term from vocabulary, 16.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   19/19 (100.00%)    
Blood and lymphatic system disorders   
Leukopenia * 1  1/19 (5.26%)  1
Ear and labyrinth disorders   
Vertigo * 1  4/19 (21.05%)  5
Eye disorders   
Dry eye * 1  1/19 (5.26%)  1
Gastrointestinal disorders   
Abdominal pain * 1  2/19 (10.53%)  3
Abdominal pain upper * 1  2/19 (10.53%)  3
Diarrhoea * 1  2/19 (10.53%)  2
Nausea * 1  2/19 (10.53%)  2
Aphthous stomatitis * 1  1/19 (5.26%)  1
Constipation * 1  1/19 (5.26%)  1
Dry mouth * 1  1/19 (5.26%)  1
Dyspepsia * 1  1/19 (5.26%)  1
Gastritis * 1  1/19 (5.26%)  1
Gastrointestinal disorder * 1  1/19 (5.26%)  1
Paraesthesia oral * 1  1/19 (5.26%)  1
General disorders   
Chest pain * 1  1/19 (5.26%)  1
Irritability * 1  1/19 (5.26%)  1
Malaise * 1  1/19 (5.26%)  1
Pyrexia * 1  1/19 (5.26%)  1
Hepatobiliary disorders   
Hepatic steatosis * 1  1/19 (5.26%)  1
Infections and infestations   
Nasopharyngitis * 1  7/19 (36.84%)  13
Influenza * 1  2/19 (10.53%)  2
Acute tonsillitis * 1  1/19 (5.26%)  2
Bronchitis * 1  1/16 (6.25%)  1
Cystitis * 1  1/19 (5.26%)  2
Herpes virus infection * 1  1/19 (5.26%)  1
Infected dermal cyst * 1  1/19 (5.26%)  1
Laryngitis * 1  1/19 (5.26%)  1
Periodontitis * 1  1/19 (5.26%)  1
Pharyngitis * 1  1/19 (5.26%)  1
Tinea pedis * 1  1/19 (5.26%)  1
Injury, poisoning and procedural complications   
Arthropod bite * 1  2/19 (10.53%)  4
Contusion * 1  1/19 (5.26%)  1
Head injury * 1  1/19 (5.26%)  1
Heat illness * 1  1/19 (5.26%)  1
Injury * 1  1/19 (5.26%)  1
Ligament sprain * 1  1/19 (5.26%)  1
Tooth fracture * 1  1/19 (5.26%)  1
Investigations   
Blood growth hormone increased * 1  1/19 (5.26%)  1
Crystal urine present * 1  1/19 (5.26%)  1
Gamma-glutamyltransferase increased * 1  1/19 (5.26%)  2
White blood cell count decreased * 1  1/19 (5.26%)  1
Metabolism and nutrition disorders   
Decreased appetite * 1  1/19 (5.26%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/19 (5.26%)  2
Pubic pain * 1  1/19 (5.26%)  1
Tenosynovitis * 1  1/19 (5.26%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Fibrous histiocytoma * 1  1/19 (5.26%)  1
Nervous system disorders   
Dizziness * 1  10/19 (52.63%)  13
Somnolence * 1  8/19 (42.11%)  9
Headache * 1  3/19 (15.79%)  5
Tremor * 1  2/19 (10.53%)  2
Cerebellar ataxia * 1  1/19 (5.26%)  1
Complex partial seizures * 1  1/19 (5.26%)  1
Hypoaesthesia * 1  1/19 (5.26%)  1
Simple partial seizures * 1  1/19 (5.26%)  1
Sudden onset of sleep * 1  1/19 (5.26%)  1
Psychiatric disorders   
Depressed mood * 1  1/19 (5.26%)  1
Insomnia * 1  1/19 (5.26%)  1
Reproductive system and breast disorders   
Uterine polyp * 1  1/19 (5.26%)  1
Respiratory, thoracic and mediastinal disorders   
Vocal cord inflammation * 1  1/19 (5.26%)  1
Skin and subcutaneous tissue disorders   
Eczema * 1  3/19 (15.79%)  3
Chloasma * 1  1/19 (5.26%)  1
Dermatitis allergic * 1  1/19 (5.26%)  1
Eczema asteatotic * 1  1/19 (5.26%)  1
Pustular psoriasis * 1  1/19 (5.26%)  1
Urticaria * 1  1/19 (5.26%)  1
1
Term from vocabulary, 16.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844599 ext 2273
EMail: UCBCares@ucb.comTokyo
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT02124564    
Other Study ID Numbers: EP0057
First Submitted: April 24, 2014
First Posted: April 28, 2014
Results First Submitted: November 21, 2018
Results First Posted: June 28, 2019
Last Update Posted: October 28, 2019