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Trial record 1 of 1 for:    NCT00530855
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Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for 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: NCT00530855
Recruitment Status : Completed
First Posted : September 18, 2007
Results First Posted : June 3, 2015
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 322
Recruitment Details This Multicenter, Open-Label Study started to enroll Subjects in February 2008.
Pre-assignment Details Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide tablets for dosing 100 -800 mg/day
Period Title: Overall Study
Started 322
Completed 210
Not Completed 112
Reason Not Completed
Lack of Efficacy             20
Withdrawal by Subject             30
Fatal Serious AE             3
Non Fatal Serious AE             7
Non Fatal Non Serious AE             12
Protocol Violation             3
Unsatisfactory compliance of subject             11
Lost to Follow-up             9
Other reason for premature termination             17
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide tablets for dosing 100 -800 mg/day
Overall Number of Baseline Participants 322
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants
<=18 years
8
   2.5%
Between 18 and 65 years
301
  93.5%
>=65 years
13
   4.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
mean (standard deviation) Number Analyzed 322 participants
40.7  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 322 participants
Female
161
  50.0%
Male
161
  50.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 322 participants
White 258
Black or African American 46
Asian 1
Other 17
1.Primary Outcome
Title Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Hide Description Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Time Frame From Visit 1 to End of Study (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide tablets for dosing 100 -800 mg/day
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
292
2.Primary Outcome
Title Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Hide Description Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Time Frame From Visit 1 to End of Study (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide tablets for dosing 100 -800 mg/day
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: days
479.1  (271.9)
3.Secondary Outcome
Title Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
Hide Description

A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases.

An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).

Time Frame From Visit 1 to End of Study (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide tablets for dosing 100 -800 mg/day
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
296
4.Secondary Outcome
Title Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
Hide Description [Not Specified]
Time Frame From Visit 1 to End of Study (approximately 2 years)
Hide Outcome Measure Data
Hide Analysis Population Description
All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide tablets for dosing 100 -800 mg/day
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
22
Time Frame Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Event Reporting Description Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
 
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide tablets for dosing 100 -800 mg/day
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   56/322 (17.39%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/322 (0.31%)  1
Cardiac disorders   
Congestive cardiomyopathy * 1  1/322 (0.31%)  1
Angina unstable * 1  1/322 (0.31%)  1
Bradycardia * 1  1/322 (0.31%)  1
Cardiac arrest * 1  1/322 (0.31%)  1
Cardiac tamponade * 1  1/322 (0.31%)  1
Eye disorders   
Vision blurred * 1  1/322 (0.31%)  1
Gastrointestinal disorders   
Intestinal obstruction * 1  1/322 (0.31%)  1
Melaena * 1  1/322 (0.31%)  1
General disorders   
Pyrexia * 1  1/322 (0.31%)  2
Sudden unexplained death in epilepsy * 1  1/322 (0.31%)  1
Chest pain * 1  1/322 (0.31%)  1
Pain * 1  1/322 (0.31%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/322 (0.31%)  1
Infections and infestations   
Appendicitis * 1  1/322 (0.31%)  1
Bacteraemia * 1  1/322 (0.31%)  1
Gastroenteritis * 1  1/322 (0.31%)  1
Pneumonia * 1  1/322 (0.31%)  1
Sepsis * 1  1/322 (0.31%)  1
Cellulitis * 1  1/322 (0.31%)  1
Tubo-ovarian abscess * 1  1/322 (0.31%)  1
Urinary tract infection * 1  1/322 (0.31%)  1
Injury, poisoning and procedural complications   
Rib fracture * 1  2/322 (0.62%)  2
Cervical vertebral fracture * 1  1/322 (0.31%)  1
Concussion * 1  1/322 (0.31%)  1
Contusion * 1  1/322 (0.31%)  1
Foot fracture * 1  1/322 (0.31%)  1
Laceration * 1  1/322 (0.31%)  1
Pulmonary contusion * 1  1/322 (0.31%)  1
Road traffic accident * 1  1/322 (0.31%)  2
Ankle fracture * 1  1/322 (0.31%)  1
Fall * 1  1/322 (0.31%)  3
Head injury * 1  1/322 (0.31%)  1
Post procedural haemorrhage * 1  1/322 (0.31%)  1
Tendon rupture * 1  1/322 (0.31%)  1
Toxicity to various agents * 1  1/322 (0.31%)  1
Investigations   
Electroencephalogram * 1  1/322 (0.31%)  1
Heart rate decreased * 1  1/322 (0.31%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc disorder * 1  1/322 (0.31%)  1
Rotator cuff syndrome * 1  1/322 (0.31%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer stage II * 1  1/322 (0.31%)  1
Cervix carcinoma * 1  1/322 (0.31%)  1
Colon neoplasm * 1  1/322 (0.31%)  1
Metastatic squamous cell carcinoma * 1  1/322 (0.31%)  1
Nervous system disorders   
Convulsion * 1  17/322 (5.28%)  19
Status epilepticus * 1  4/322 (1.24%)  6
Syncope * 1  3/322 (0.93%)  3
Postictal state * 1  2/322 (0.62%)  2
Complicated migraine * 1  1/322 (0.31%)  1
Depressed level of consciousness * 1  1/322 (0.31%)  1
Dizziness * 1  1/322 (0.31%)  1
Hydrocephalus * 1  1/322 (0.31%)  1
Transient ischaemic attack * 1  1/322 (0.31%)  1
Brain oedema * 1  1/322 (0.31%)  1
Cerebrovascular accident * 1  1/322 (0.31%)  1
Dyskinesia * 1  1/322 (0.31%)  1
Grand mal convulsion * 1  1/322 (0.31%)  2
Migraine * 1  1/322 (0.31%)  1
Psychiatric disorders   
Acute psychosis * 1  1/322 (0.31%)  1
Confusional state * 1  1/322 (0.31%)  1
Delirium * 1  1/322 (0.31%)  1
Suicidal ideation * 1  1/322 (0.31%)  1
Postictal psychosis * 1  1/322 (0.31%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  1/322 (0.31%)  1
Respiratory, thoracic and mediastinal disorders   
Cough * 1  1/322 (0.31%)  1
Skin and subcutaneous tissue disorders   
Seborrhoeic dermatitis * 1  1/322 (0.31%)  1
Vascular disorders   
Hypotension * 1  1/322 (0.31%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   238/322 (73.91%)    
Gastrointestinal disorders   
Nausea * 1  46/322 (14.29%)  68
Vomiting * 1  27/322 (8.39%)  37
Diarrhoea * 1  23/322 (7.14%)  27
General disorders   
Fatigue * 1  40/322 (12.42%)  44
Infections and infestations   
Upper respiratory tract infection * 1  45/322 (13.98%)  53
Nasopharyngitis * 1  38/322 (11.80%)  53
Urinary tract infection * 1  20/322 (6.21%)  30
Influenza * 1  19/322 (5.90%)  23
Injury, poisoning and procedural complications   
Fall * 1  31/322 (9.63%)  44
Contusion * 1  25/322 (7.76%)  49
Laceration * 1  22/322 (6.83%)  32
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  31/322 (9.63%)  41
Back pain * 1  17/322 (5.28%)  18
Nervous system disorders   
Dizziness * 1  89/322 (27.64%)  142
Headache * 1  55/322 (17.08%)  81
Convulsion * 1  29/322 (9.01%)  42
Tremor * 1  26/322 (8.07%)  30
Psychiatric disorders   
Anxiety * 1  24/322 (7.45%)  26
Insomnia * 1  20/322 (6.21%)  24
Depression * 1  17/322 (5.28%)  21
Skin and subcutaneous tissue disorders   
Rash * 1  20/322 (6.21%)  31
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA16.1
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 Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00530855    
Other Study ID Numbers: SP0904
2007-005440-25 ( EudraCT Number )
First Submitted: September 14, 2007
First Posted: September 18, 2007
Results First Submitted: May 18, 2015
Results First Posted: June 3, 2015
Last Update Posted: July 18, 2018