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Trial record 1 of 1 for:    NCT00522275
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Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

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ClinicalTrials.gov Identifier: NCT00522275
Recruitment Status : Completed
First Posted : August 29, 2007
Results First Posted : November 22, 2010
Last Update Posted : July 18, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Epilepsies
Intervention Drug: lacosamide
Enrollment 308
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lacosamide
Hide Arm/Group Description Up to 800 mg/day lacosamide (flexible dosing)
Period Title: Overall Study
Started 308
Completed 138
Not Completed 170
Reason Not Completed
Adverse Event             35
Lack of Efficacy             80
Subject withdrew consent             16
Protocol deviation             1
Unsatisfactory compliance             11
Lost to Follow-up             8
Other: Subject wants to become pregnant             2
Other: Subject is pregnant             2
Other: Subject relocated             2
Other: Subject arrested             1
Other: Site / clinic closed             4
Other: Travel to / from site difficulty             3
Other: Sponsor request             2
Other: Subject ran out of medication             1
Other: Subject had surgery for epilepsy             2
Arm/Group Title Lacosamide
Hide Arm/Group Description Up to 800 mg/day lacosamide (flexible dosing)
Overall Number of Baseline Participants 308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants
<=18 years
6
   1.9%
Between 18 and 65 years
295
  95.8%
>=65 years
7
   2.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 308 participants
38.2  (12.46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 308 participants
Female
146
  47.4%
Male
162
  52.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 308 participants
308
1.Primary Outcome
Title Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 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 (Maximum 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 308 subjects who entered the study, 308 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:
Up to 800 mg/day lacosamide (flexible dosing)
Overall Number of Participants Analyzed 308
Measure Type: Number
Unit of Measure: subjects
288
2.Primary Outcome
Title Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 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 (Maximum 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 308 subjects who entered the study, 308 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:
Up to 800 mg/day lacosamide (flexible dosing)
Overall Number of Participants Analyzed 308
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 (Maximum 6 Years)
Hide Description Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame During the Treatment Period (Maximum 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 308 subjects who entered the study, 308 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:
Up to 800 mg/day lacosamide (flexible dosing)
Overall Number of Participants Analyzed 308
Measure Type: Number
Unit of Measure: subjects
71
4.Secondary Outcome
Title Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Hide Description Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time Frame Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 308 subjects who were enrolled/treated in the study, 307 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 SP756 study.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Up to 800 mg/day lacosamide (flexible dosing)
Overall Number of Participants Analyzed 307
Median (Full Range)
Unit of Measure: percentage change
-48.5
(-100.0 to 567.7)
5.Secondary Outcome
Title Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 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.
Time Frame Treatment Period (Maximum 6 years)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 308 subjects who were enrolled/treated in the study, 307 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 SP756 study.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Up to 800 mg/day lacosamide (flexible dosing)
Overall Number of Participants Analyzed 307
Measure Type: Number
Unit of Measure: percentage of subjects
48.2
Time Frame Maximum of 6 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description Up to 800 mg/day lacosamide (flexible dosing)
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   71/308 (23.05%)    
Cardiac disorders   
Atrial fibrillation * 1  2/308 (0.65%)  2
Ventricular extrasystoles * 1  2/308 (0.65%)  2
Angina pectoris * 1  1/308 (0.32%)  1
Coronary artery stenosis * 1  1/308 (0.32%)  1
Supraventricular tachycardia * 1  1/308 (0.32%)  1
Cardio-respiratory arrest * 1  1/308 (0.32%)  1
Eye disorders   
Diplopia * 1  1/308 (0.32%)  1
Gastrointestinal disorders   
Vomiting * 1  4/308 (1.30%)  4
Nausea * 1  2/308 (0.65%)  2
Gastrointestinal haemorrhage * 1  2/308 (0.65%)  2
Dyspepsia * 1  1/308 (0.32%)  1
Small intestinal obstruction * 1  1/308 (0.32%)  1
Abdominal pain * 1  1/308 (0.32%)  2
Haematemesis * 1  1/308 (0.32%)  1
Mesenteric vein thrombosis * 1  1/308 (0.32%)  1
Peptic ulcer * 1  1/308 (0.32%)  1
Rectal haemorrhage * 1  1/308 (0.32%)  1
Gastrooesophagitis * 1  1/308 (0.32%)  1
General disorders   
Chest pain * 1  5/308 (1.62%)  6
Asthenia * 1  2/308 (0.65%)  2
Pyrexia * 1  1/308 (0.32%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/308 (0.32%)  1
Chronic hepatitis * 1  1/308 (0.32%)  1
Immune system disorders   
Hypersensitivity * 1  1/308 (0.32%)  1
Infections and infestations   
Pneumonia * 1  5/308 (1.62%)  5
Cystitis * 1  1/308 (0.32%)  1
Enterobacter pneumonia * 1  1/308 (0.32%)  1
Meningitis viral * 1  1/308 (0.32%)  1
Wound infection * 1  1/308 (0.32%)  1
Influenza * 1  1/308 (0.32%)  1
Salpingitis * 1  1/308 (0.32%)  1
Injury, poisoning and procedural complications   
Fall * 1  2/308 (0.65%)  2
Drug toxicity * 1  1/308 (0.32%)  1
Facial bones fracture * 1  1/308 (0.32%)  1
Skin laceration * 1  1/308 (0.32%)  1
Traumatic haematoma * 1  1/308 (0.32%)  1
Excoriation * 1  1/308 (0.32%)  1
Limb injury * 1  1/308 (0.32%)  1
Skull fracture * 1  1/308 (0.32%)  1
Multiple fractures * 1  1/308 (0.32%)  1
Accidental overdose * 1  1/308 (0.32%)  1
Operative haemorrhage * 1  1/308 (0.32%)  1
Subdural haematoma * 1  1/308 (0.32%)  1
Burns third degree * 1  1/308 (0.32%)  1
Hip fracture * 1  1/308 (0.32%)  1
Jaw fracture * 1  1/308 (0.32%)  1
Investigations   
Hepatic enzyme increased * 1  1/308 (0.32%)  1
Electrocardiogram QT corrected interval prolonged * 1  1/308 (0.32%)  1
Blood pressure increased * 1  1/308 (0.32%)  1
Metabolism and nutrition disorders   
Dehydration * 1  3/308 (0.97%)  4
Anorexia * 1  1/308 (0.32%)  1
Hyponatraemia * 1  1/308 (0.32%)  1
Musculoskeletal and connective tissue disorders   
Intervertebral disc protrusion * 1  1/308 (0.32%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Testis cancer * 1  1/308 (0.32%)  1
Basal cell carcinoma * 1  1/308 (0.32%)  1
Breast cancer * 1  1/308 (0.32%)  1
Nervous system disorders   
Convulsion * 1  11/308 (3.57%)  13
Dizziness * 1  4/308 (1.30%)  4
Status epilepticus * 1  3/308 (0.97%)  3
Coordination abnormal * 1  2/308 (0.65%)  2
Complex partial seizures * 1  1/308 (0.32%)  1
Headache * 1  1/308 (0.32%)  1
Transient ischaemic attack * 1  1/308 (0.32%)  1
Grand mal convulsion * 1  1/308 (0.32%)  1
Myoclonus * 1  1/308 (0.32%)  1
Subarachnoid haemorrhage * 1  1/308 (0.32%)  1
Psychiatric disorders   
Mental status changes * 1  3/308 (0.97%)  3
Suicidal ideation * 1  3/308 (0.97%)  3
Depression * 1  2/308 (0.65%)  2
Suicide attempt * 1  1/308 (0.32%)  2
Aggression * 1  1/308 (0.32%)  1
Psychotic disorder * 1  1/308 (0.32%)  1
Sleep attacks * 1  1/308 (0.32%)  1
Abnormal behaviour * 1  1/308 (0.32%)  1
Paranoia * 1  1/308 (0.32%)  1
Anxiety * 1  1/308 (0.32%)  1
Renal and urinary disorders   
Nephrolithiasis * 1  2/308 (0.65%)  2
Renal failure acute * 1  1/308 (0.32%)  1
Haematuria * 1  1/308 (0.32%)  1
Renal failure * 1  1/308 (0.32%)  1
Reproductive system and breast disorders   
Ovarian cyst * 1  2/308 (0.65%)  2
Priapism * 1  1/308 (0.32%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax * 1  2/308 (0.65%)  2
Pulmonary oedema * 1  1/308 (0.32%)  1
Haemoptysis * 1  1/308 (0.32%)  2
Skin and subcutaneous tissue disorders   
Angioneurotic oedema * 1  1/308 (0.32%)  1
Surgical and medical procedures   
Vagal nerve stimulator implantation * 1  1/308 (0.32%)  1
Vascular disorders   
Thrombosis * 1  1/308 (0.32%)  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   265/308 (86.04%)    
Eye disorders   
Diplopia * 1  46/308 (14.94%)  72
Vision blurred * 1  28/308 (9.09%)  39
Gastrointestinal disorders   
Nausea * 1  56/308 (18.18%)  78
Vomiting * 1  47/308 (15.26%)  66
Diarrhoea * 1  25/308 (8.12%)  32
Constipation * 1  22/308 (7.14%)  22
General disorders   
Fatigue * 1  36/308 (11.69%)  45
Irritability * 1  19/308 (6.17%)  21
Gait disturbance * 1  18/308 (5.84%)  22
Infections and infestations   
Nasopharyngitis * 1  53/308 (17.21%)  83
Upper respiratory tract infection * 1  40/308 (12.99%)  54
Sinusitis * 1  32/308 (10.39%)  46
Influenza * 1  26/308 (8.44%)  28
Urinary tract infection * 1  25/308 (8.12%)  37
Bronchitis * 1  17/308 (5.52%)  23
Injury, poisoning and procedural complications   
Contusion * 1  57/308 (18.51%)  90
Fall * 1  47/308 (15.26%)  93
Skin laceration * 1  38/308 (12.34%)  69
Joint sprain * 1  19/308 (6.17%)  20
Excoriation * 1  18/308 (5.84%)  38
Head injury * 1  17/308 (5.52%)  21
Investigations   
Weight increased * 1  17/308 (5.52%)  17
Gamma-glutamyltransferase increased * 1  17/308 (5.52%)  17
Musculoskeletal and connective tissue disorders   
Back pain * 1  34/308 (11.04%)  46
Arthralgia * 1  18/308 (5.84%)  26
Pain in extremity * 1  16/308 (5.19%)  24
Nervous system disorders   
Dizziness * 1  154/308 (50.00%)  260
Headache * 1  67/308 (21.75%)  91
Convulsion * 1  44/308 (14.29%)  62
Tremor * 1  41/308 (13.31%)  57
Balance disorder * 1  41/308 (13.31%)  51
Nystagmus * 1  34/308 (11.04%)  37
Coordination abnormal * 1  26/308 (8.44%)  30
Somnolence * 1  25/308 (8.12%)  28
Memory impairment * 1  20/308 (6.49%)  21
Psychiatric disorders   
Depression * 1  35/308 (11.36%)  45
Insomnia * 1  28/308 (9.09%)  38
Anxiety * 1  17/308 (5.52%)  20
Respiratory, thoracic and mediastinal disorders   
Pharyngolaryngeal pain * 1  27/308 (8.77%)  29
Cough * 1  20/308 (6.49%)  23
Skin and subcutaneous tissue disorders   
Rash * 1  20/308 (6.49%)  21
*
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 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
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT00522275    
Other Study ID Numbers: SP0756
2014-004398-18 ( EudraCT Number )
First Submitted: August 27, 2007
First Posted: August 29, 2007
Results First Submitted: October 28, 2010
Results First Posted: November 22, 2010
Last Update Posted: July 18, 2018