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Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

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ClinicalTrials.gov Identifier: NCT00515619
Recruitment Status : Completed
First Posted : August 14, 2007
Results First Posted : September 9, 2011
Last Update Posted : August 28, 2017
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 376
Recruitment Details The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010.
Pre-assignment Details Safety Set consists of all subjects who received at least 1 dose of Lacosamide.
Arm/Group Title Lacosamide
Hide Arm/Group Description 50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Period Title: Overall Study
Started 376
Safety Set 376
Completed 160
Not Completed 216
Reason Not Completed
Adverse Event             34
Lack of Efficacy             92
Withdrawal by Subject             66
Protocol Violation             3
Lost to Follow-up             4
Unsatisfactory compliance             6
Other: Site discontinuing trials             2
Other: Subject cannot attend visits             2
Other: Subject required surgery             1
Other: Subject moved to another country             1
Other: Investigator decision             1
Other: Subject became pregnant             1
Other: Request from sponsor             1
Other: Drug available on license             1
Other: Subject interested in other AED             1
Arm/Group Title Lacosamide
Hide Arm/Group Description 50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Overall Number of Baseline Participants 376
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants
<=18 years
7
   1.9%
Between 18 and 65 years
366
  97.3%
>=65 years
3
   0.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 376 participants
37.8  (11.53)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 376 participants
Female
169
  44.9%
Male
207
  55.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 376 participants
Finland 16
Spain 26
Lithuania 42
Russian Federation 31
United Kingdom 20
France 10
Czech Republic 50
Hungary 31
Poland 37
Croatia 31
Australia 31
Germany 35
Sweden 16
1.Primary Outcome
Title Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame During the Treatment Period (up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 376
Measure Type: Number
Unit of Measure: Subjects
311
2.Primary Outcome
Title Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)
Hide Description Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame During the Treatment Period (up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 376
Measure Type: Number
Unit of Measure: Subjects
33
3.Primary Outcome
Title Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)
Hide Description A serious adverse event is any untoward medical occurrences in a subject administered study treatment, whether or not the event is related to treatment, with at least one of the follow outcomes: death, life-threatening, initial inpatient hospitalization or prolongation of hospitalization, significant or persistent disability/incapacity, congenital anomaly/birth defect, or an important medical event that may jeopardize the subject and require a medical/surgical intervention.
Time Frame During the Treatment Period (up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 376 subjects who entered the study, 376 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 376
Measure Type: Number
Unit of Measure: Subjects
87
4.Secondary Outcome
Title Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)
Hide Description

Median percentage change is the median value with respect to the percent change from Baseline across the population of subjects. Percentage change is calculated as 100 times the difference of the seizure frequency for the treatment period and the Baseline seizure frequency divided by the baseline seizure frequency.

Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time Frame Baseline, Treatment Period (up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 376
Median (Full Range)
Unit of Measure: Percentage change
-49.9
(-100.0 to 422.8)
5.Secondary Outcome
Title Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)
Hide Description At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study. This endpoint reflects the percentage of subjects with at least 50% reduction (ie, at least 50% change) in 28-day partial onset seizure frequency
Time Frame Treatment Period (up to 5.5 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 376 subjects who were enrolled/treated in the study, 376 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP774 study.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
Overall Number of Participants Analyzed 376
Measure Type: Number
Unit of Measure: Percentage of subjects
50.0
Time Frame The adverse event summaries are based on data collected during the 5.5 years of the study for all 376 patients
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description 50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   87/376 (23.14%)    
Blood and lymphatic system disorders   
Anaemia * 1  1/376 (0.27%)  1
Cardiac disorders   
Acute myocardial infarction * 1  1/376 (0.27%)  1
Cardiac arrest * 1  1/376 (0.27%)  1
Tachycardia * 1  1/376 (0.27%)  1
Congenital, familial and genetic disorders   
Exomphalos * 1  1/376 (0.27%)  1
Endocrine disorders   
Hyperthyroidism * 1  1/376 (0.27%)  1
Inappropriate antidiuretic hormone secretion * 1  1/376 (0.27%)  1
Eye disorders   
Diplopia * 1  1/376 (0.27%)  1
Scotoma * 1  1/376 (0.27%)  1
Eye haemorrhage * 1  1/376 (0.27%)  1
Gastrointestinal disorders   
Anal fistula * 1  1/376 (0.27%)  1
Haematemesis * 1  1/376 (0.27%)  1
Mechanical ileus * 1  1/376 (0.27%)  1
General disorders   
Chest pain * 1  2/376 (0.53%)  2
Chest discomfort * 1  1/376 (0.27%)  1
Hepatobiliary disorders   
Hepatomegaly * 1  1/376 (0.27%)  1
Cholecystitis * 1  1/376 (0.27%)  1
Infections and infestations   
Gastroenteritis * 1  1/376 (0.27%)  1
Abscess limb * 1  1/376 (0.27%)  1
Appendicitis * 1  1/376 (0.27%)  1
Postoperative wound infection * 1  1/376 (0.27%)  1
Intervertebral discitis * 1  1/376 (0.27%)  1
Sepsis * 1  1/376 (0.27%)  1
Pilonidal cyst * 1  1/376 (0.27%)  1
Pneumonia * 1  1/376 (0.27%)  1
Injury, poisoning and procedural complications   
Head injury * 1  3/376 (0.80%)  3
Subdural haematoma * 1  3/376 (0.80%)  3
Brain contusion * 1  3/376 (0.80%)  3
Lower limb fracture * 1  3/376 (0.80%)  3
Skin laceration * 1  2/376 (0.53%)  2
Contusion * 1  1/376 (0.27%)  3
Fall * 1  1/376 (0.27%)  1
Skull fracture * 1  1/376 (0.27%)  1
Jaw fracture * 1  1/376 (0.27%)  1
Pelvic fracture * 1  1/376 (0.27%)  1
Rib fracture * 1  1/376 (0.27%)  1
Lumbar vertebral fracture * 1  1/376 (0.27%)  1
Wrist fracture * 1  1/376 (0.27%)  1
Skeletal injury * 1  1/376 (0.27%)  1
Soft tissue injury * 1  1/376 (0.27%)  1
Tooth fracture * 1  1/376 (0.27%)  1
Investigations   
Weight decreased * 1  1/376 (0.27%)  1
Electrocardiogram QT corrected interval prolonged * 1  1/376 (0.27%)  1
Investigation * 1  1/376 (0.27%)  1
Metabolism and nutrition disorders   
Hyponatraemia * 1  1/376 (0.27%)  1
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/376 (0.27%)  1
Fibromyalgia * 1  1/376 (0.27%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma * 1  1/376 (0.27%)  1
Brain neoplasm malignant * 1  1/376 (0.27%)  1
Breast Cancer * 1  1/376 (0.27%)  1
Nervous system disorders   
Convulsion * 1  15/376 (3.99%)  21
Epilepsy * 1  7/376 (1.86%)  8
Status epilepticus * 1  5/376 (1.33%)  5
Grand mal convulsion * 1  3/376 (0.80%)  3
Headache * 1  2/376 (0.53%)  2
Hydrocephalus * 1  2/376 (0.53%)  2
Coordination abnormal * 1  2/376 (0.53%)  2
Subarachnoid haemorrhage * 1  2/376 (0.53%)  2
Monoparesis * 1  1/376 (0.27%)  1
Somnolence * 1  1/376 (0.27%)  1
Cerebral haematoma * 1  1/376 (0.27%)  1
Paresis * 1  1/376 (0.27%)  1
Sciatica * 1  1/376 (0.27%)  1
Visual field defect * 1  1/376 (0.27%)  1
Cerebral haemorrhage * 1  1/376 (0.27%)  1
Complex partial seizures * 1  1/376 (0.27%)  1
Encephalitis * 1  1/376 (0.27%)  1
Aura * 1  1/376 (0.27%)  1
Hemiparesis * 1  1/376 (0.27%)  1
Intracranial pressure increased * 1  1/376 (0.27%)  1
Simple partial seizures * 1  1/376 (0.27%)  1
Psychiatric disorders   
Depression * 1  2/376 (0.53%)  2
Epileptic psychosis * 1  2/376 (0.53%)  3
Aggression * 1  1/376 (0.27%)  1
Suicide attempt * 1  1/376 (0.27%)  1
Suicidal ideation * 1  1/376 (0.27%)  1
Pathological gambling * 1  1/376 (0.27%)  1
Confusional state * 1  1/376 (0.27%)  1
Renal and urinary disorders   
Calculus ureteric * 1  1/376 (0.27%)  1
Reproductive system and breast disorders   
Metrorrhagia * 1  2/376 (0.53%)  2
Ovarian cyst * 1  2/376 (0.53%)  2
Bartholin's cyst * 1  1/376 (0.27%)  1
Uterine polyp * 1  1/376 (0.27%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal septum deviation * 1  2/376 (0.53%)  2
Dyspnoea * 1  1/376 (0.27%)  1
Bronchial disorder * 1  1/376 (0.27%)  1
Pulmonary embolism * 1  1/376 (0.27%)  1
Skin and subcutaneous tissue disorders   
Rash * 1  1/376 (0.27%)  1
Social circumstances   
Breast prosthesis user * 1  1/376 (0.27%)  1
Surgical and medical procedures   
Shoulder operation * 1  1/376 (0.27%)  1
Knee meniscectomy * 1  1/376 (0.27%)  1
Hospitalisation * 1  1/376 (0.27%)  1
Therapeutic procedure * 1  1/376 (0.27%)  1
Vascular disorders   
Ischaemia * 1  1/376 (0.27%)  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   232/376 (61.70%)    
Ear and labyrinth disorders   
Vertigo * 1  31/376 (8.24%)  35
Eye disorders   
Diplopia * 1  51/376 (13.56%)  63
Gastrointestinal disorders   
Vomiting * 1  25/376 (6.65%)  33
General disorders   
Fatigue * 1  22/376 (5.85%)  25
Infections and infestations   
Nasopharyngitis * 1  52/376 (13.83%)  77
Injury, poisoning and procedural complications   
Contusion * 1  20/376 (5.32%)  29
Musculoskeletal and connective tissue disorders   
Back pain * 1  28/376 (7.45%)  38
Nervous system disorders   
Dizziness * 1  91/376 (24.20%)  157
Headache * 1  54/376 (14.36%)  97
Somnolence * 1  27/376 (7.18%)  34
Tremor * 1  23/376 (6.12%)  31
Balance disorder * 1  19/376 (5.05%)  25
Convulsion * 1  19/376 (5.05%)  23
Psychiatric disorders   
Depression * 1  19/376 (5.05%)  20
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
[Not Specified]
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 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 the results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Publications of Results:
Borghs S, de la Loge C, Brabant Y, Cramer J. Sensitivity testing of the Seizure Severity Questionnaire (SSQ). Epilepsy Behav. 2014 Feb;31:281-5. doi: 10.1016/j.yebeh.2013.10.010. Epub 2013 Nov 22.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00515619    
Other Study ID Numbers: SP0774
2004-000152-16 ( EudraCT Number )
First Submitted: August 13, 2007
First Posted: August 14, 2007
Results First Submitted: August 5, 2011
Results First Posted: September 9, 2011
Last Update Posted: August 28, 2017