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Trial record 1 of 1 for:    NCT00655486
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Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT00655486
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : July 15, 2011
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Partial Epilepsies
Partial Onset Seizures
Intervention Drug: lacosamide
Enrollment 97
Recruitment Details The study started in April 2008 with enrollment occuring in the United States only. The study completed June 2010
Pre-assignment Details  
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Period Title: Overall Study
Started 97
Completed 69
Not Completed 28
Reason Not Completed
Adverse Event             10
Lack of Efficacy             8
Withdrawal by Subject             4
Protocol Violation             1
Unsatisfactory compliance             2
Other: Pregnancy             1
Other: Could not tolerate BID dosing             1
Other: Abnormal electrocardiogram (ECG)             1
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Overall Number of Baseline Participants 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
<=18 years
2
   2.1%
Between 18 and 65 years
95
  97.9%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants
38.8  (11.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants
Female
47
  48.5%
Male
50
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 97 participants
97
1.Primary Outcome
Title Number of Subjects With at Least One Adverse Event During This Open-label Extension Study (Maximum Study Duration 2 Years)
Hide Description An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: subjects
93
2.Primary Outcome
Title Number of Subjects Who Withdrew From the Study Due to an Adverse Event (Maximum Study Duration 2 Years)
Hide Description An Adverse Event (AE) is 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 period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All 97 subjects enrolled are in the Safety Set (SS) and are included in this analysis
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: subjects
10
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide 100 to 800 mg/day, flexible dosing, administered twice daily throughout the duration of the study (up to 2 years)
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   10/97 (10.31%)    
Cardiac disorders   
Arrhythmia supraventricular * 1  1/97 (1.03%)  1
Atrial fibrillation * 1  1/97 (1.03%)  1
General disorders   
Chest pain * 1  1/97 (1.03%)  1
Drug interaction * 1  1/97 (1.03%)  1
Infections and infestations   
Giardiasis * 1  1/97 (1.03%)  1
Pneumonia * 1  1/97 (1.03%)  1
Sepsis * 1  1/97 (1.03%)  1
Injury, poisoning and procedural complications   
Post procedural bile leak * 1  1/97 (1.03%)  1
Nervous system disorders   
Convulsion * 1  2/97 (2.06%)  2
Lethargy * 1  1/97 (1.03%)  1
Psychiatric disorders   
Hallucination * 1  1/97 (1.03%)  1
Homicidal ideation * 1  1/97 (1.03%)  1
Paranoia * 1  1/97 (1.03%)  1
Depression suicidal * 1  1/97 (1.03%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   88/97 (90.72%)    
Ear and labyrinth disorders   
Tinnitus * 1  5/97 (5.15%)  5
Eye disorders   
Diplopia * 1  17/97 (17.53%)  18
Vision blurred * 1  10/97 (10.31%)  10
Gastrointestinal disorders   
Vomiting * 1  16/97 (16.49%)  18
Nausea * 1  13/97 (13.40%)  14
Diarrhoea * 1  12/97 (12.37%)  13
Constipation * 1  5/97 (5.15%)  6
General disorders   
Fatigue * 1  12/97 (12.37%)  12
Chest pain * 1  8/97 (8.25%)  9
Irritability * 1  5/97 (5.15%)  6
Infections and infestations   
Upper respiratory tract infection * 1  14/97 (14.43%)  17
Sinusitis * 1  8/97 (8.25%)  11
Urinary tract infection * 1  7/97 (7.22%)  8
Nasopharyngitis * 1  6/97 (6.19%)  7
Injury, poisoning and procedural complications   
Contusion * 1  5/97 (5.15%)  5
Investigations   
Weight increased * 1  6/97 (6.19%)  6
Nervous system disorders   
Dizziness * 1  43/97 (44.33%)  50
Somnolence * 1  12/97 (12.37%)  13
Coordination abnormal * 1  11/97 (11.34%)  13
Headache * 1  11/97 (11.34%)  11
Balance disorder * 1  11/97 (11.34%)  13
Tremor * 1  8/97 (8.25%)  10
Memory impairment * 1  5/97 (5.15%)  5
Hypoaesthesia * 1  5/97 (5.15%)  7
Psychiatric disorders   
Insomnia * 1  9/97 (9.28%)  9
Confusional state * 1  8/97 (8.25%)  8
Depression * 1  7/97 (7.22%)  7
Skin and subcutaneous tissue disorders   
Rash * 1  5/97 (5.15%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB, Inc
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT00655486    
Other Study ID Numbers: SP0926
2014-004384-21 ( EudraCT Number )
First Submitted: March 26, 2008
First Posted: April 10, 2008
Results First Submitted: June 15, 2011
Results First Posted: July 15, 2011
Last Update Posted: July 17, 2018