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Trial record 2 of 2 for:    NCT01710657

Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With 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: NCT01832038
Recruitment Status : Completed
First Posted : April 15, 2013
Results First Posted : August 13, 2020
Last Update Posted : August 17, 2021
Sponsor:
Collaborator:
UCB Japan Co. Ltd.
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

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 473
Recruitment Details The study started to enroll participants in March 2013 and concluded in July 2019.
Pre-assignment Details Participant Flow refers to the Safety Set.
Arm/Group Title Lacosamide
Hide Arm/Group Description At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day lacosamide (LCM). The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion.
Period Title: Overall Study
Started 473
Completed 238
Not Completed 235
Reason Not Completed
Death             5
Adverse Event             50
Lack of Efficacy             81
Protocol Violation             7
Lost to Follow-up             10
Withdrawal by Subject             49
Visit non-compliance             2
Subject refused to return visit             2
Not convenient to come back to site             2
Participant was asked to quit             5
Back home             1
Pregnancy             1
Low compliance             3
Prohibit procedure             2
Not possible to visit the hospital             1
Changes of implementation system             3
Plan to pregnancy             7
Bad mood and has suicidal thought             1
Prohibited concomitant medication             1
Pregnancy and abortion in EP0008 study             1
Subject considered the efficacy was poor             1
Arm/Group Title Lacosamide
Hide Arm/Group Description At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day lacosamide (LCM). The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion.
Overall Number of Baseline Participants 473
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Safety Set (SS) which consisted of all enrolled participants in EP0009 who took at least 1 dose of lacosamide (LCM) in EP0009.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 473 participants
<=18 years
39
   8.2%
Between 18 and 65 years
432
  91.3%
>=65 years
2
   0.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 473 participants
32.7  (12.0)
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 473 participants
Male
259
  54.8%
Female
214
  45.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 473 participants
Chinese
350
  74.0%
Japanese
123
  26.0%
1.Primary Outcome
Title Number of Participants With at Least One Adverse Event Reported Spontaneously by the Subject or Observed by the Investigator From Baseline Until the End of Study Visit
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant 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 Visit 1 (Week 0) up to approximately Week 323
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description:
At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed 473
Measure Type: Count of Participants
Unit of Measure: Participants
410
  86.7%
2.Primary Outcome
Title Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment and led to the withdrawal of the participants from the study. 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 Visit 1 (Week 0) up to approximately Week 323
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description:
At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed 473
Measure Type: Count of Participants
Unit of Measure: Participants
51
  10.8%
3.Secondary Outcome
Title Percent Change in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
Hide Description The percent change from Baseline to the Treatment Period was calculated as {[(Seizure frequency per 28 days during the Treatment Period) minus (Seizure frequency per 28 days during Baseline Period)] divided by (Seizure frequency per 28 days during Baseline Period)} multiplied by 100. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].
Time Frame From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009.
Arm/Group Title Lacosamide (FAS)
Hide Arm/Group Description:
At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 471
Mean (Standard Deviation)
Unit of Measure: Percent change
-44.47  (55.82)
4.Secondary Outcome
Title Percentage of Participants With 50 % Response Rate in Partial-onset Seizure Frequency Per 28 Days From Baseline of Study EP0008 [NCT01710657] Until the End of Study Visit in Study EP0009
Hide Description A responder is a subject experiencing a greater than or equal to (≥) 50 % reduction in partial-onset seizure frequency per 28 days from baseline. Baseline was defined as the Baseline Period of study EP0008 [NCT01710657].
Time Frame From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009
Hide Outcome Measure Data
Hide Analysis Population Description
The Full Analysis Set (FAS) included all study participants from the SS who had at least 1 day with available seizure diary data in study EP0009.
Arm/Group Title Lacosamide (FAS)
Hide Arm/Group Description:
At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Full Analysis Set (FAS).
Overall Number of Participants Analyzed 471
Measure Type: Number
Unit of Measure: percentage of participants
57.1
Time Frame Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide (SS)
Hide Arm/Group Description At the completion of EP0008 [NCT01710657], all participants who enrolled in EP0009 were administered a dose of 200 mg/day LCM. The LCM dose may have been decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day, at the investigator's discretion. Participants formed the Safety Set (SS).
All-Cause Mortality
Lacosamide (SS)
Affected / at Risk (%)
Total   6/473 (1.27%)    
Hide Serious Adverse Events
Lacosamide (SS)
Affected / at Risk (%) # Events
Total   83/473 (17.55%)    
Cardiac disorders   
Sinus bradycardia * 1  1/473 (0.21%)  1
Congenital, familial and genetic disorders   
Hamartoma * 1  1/473 (0.21%)  1
Eye disorders   
Blindness unilateral * 1  1/473 (0.21%)  1
Gastrointestinal disorders   
Duodenitis * 1  1/473 (0.21%)  1
Dyspepsia * 1  1/473 (0.21%)  1
Gastric ulcer * 1  1/473 (0.21%)  1
Gastritis * 1  2/473 (0.42%)  2
Gastritis atrophic * 1  1/473 (0.21%)  1
Gastrointestinal haemorrhage * 1  1/473 (0.21%)  1
Gastrointestinal necrosis * 1  1/473 (0.21%)  2
Gastrointestinal pain * 1  1/473 (0.21%)  1
Haemorrhoids * 1  1/473 (0.21%)  1
Hypertrophic anal papilla * 1  1/473 (0.21%)  1
Inguinal hernia, obstructive * 1  1/473 (0.21%)  1
Large intestine polyp * 1  1/473 (0.21%)  1
Rectal polyp * 1  1/473 (0.21%)  1
Rectal prolapse * 1  1/473 (0.21%)  1
Reflux gastritis * 1  1/473 (0.21%)  1
General disorders   
Pyrexia * 1  1/473 (0.21%)  1
Sudden death * 1  1/473 (0.21%)  1
Hepatobiliary disorders   
Cholecystitis * 1  1/473 (0.21%)  1
Infections and infestations   
Bacterial prostatitis * 1  1/473 (0.21%)  1
Chronic sinusitis * 1  2/473 (0.42%)  2
Encephalitis viral * 1  1/473 (0.21%)  1
Erysipelas * 1  1/473 (0.21%)  1
Gastroenteritis * 1  1/473 (0.21%)  1
Lung infection * 1  1/473 (0.21%)  1
Orchitis * 1  1/473 (0.21%)  1
Peritonitis * 1  1/473 (0.21%)  1
Peritonsillar abscess * 1  1/473 (0.21%)  1
Pneumonia * 1  6/473 (1.27%)  6
Retroperitoneal infection * 1  1/473 (0.21%)  1
Tuberculosis of genitourinary system * 1  1/473 (0.21%)  1
Upper respiratory tract infection * 1  2/473 (0.42%)  3
Injury, poisoning and procedural complications   
Ankle fracture * 1  1/473 (0.21%)  1
Brain contusion * 1  1/473 (0.21%)  1
Burns third degree * 1  1/473 (0.21%)  1
Clavicle fracture * 1  2/473 (0.42%)  2
Craniocerebral injury * 1  1/473 (0.21%)  1
Face injury * 1  1/473 (0.21%)  1
Facial bones fracture * 1  2/473 (0.42%)  3
Fibula fracture * 1  1/473 (0.21%)  1
Foreign body * 1  1/473 (0.21%)  3
Head injury * 1  1/473 (0.21%)  1
Heat stroke * 1  1/473 (0.21%)  1
Humerus fracture * 1  1/473 (0.21%)  1
Injury * 1  2/473 (0.42%)  2
Jaw fracture * 1  2/473 (0.42%)  2
Spinal compression fracture * 1  1/473 (0.21%)  1
Subdural haemorrhage * 1  1/473 (0.21%)  1
Thermal burn * 1  1/473 (0.21%)  2
Tibia fracture * 1  1/473 (0.21%)  1
Toxicity to various agents * 1  1/473 (0.21%)  1
Metabolism and nutrition disorders   
Decreased appetite * 1  1/473 (0.21%)  2
Musculoskeletal and connective tissue disorders   
Osteoarthritis * 1  1/473 (0.21%)  1
Rhabdomyolysis * 1  1/473 (0.21%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/473 (0.21%)  1
Haemangioma * 1  1/473 (0.21%)  1
Meigs' syndrome * 1  1/473 (0.21%)  1
Metastatic glioma * 1  1/473 (0.21%)  1
Ovarian fibroma * 1  1/473 (0.21%)  1
Ovarian germ cell teratoma * 1  1/473 (0.21%)  1
Nervous system disorders   
Cerebral haemorrhage * 1  1/473 (0.21%)  1
Cerebral infarction * 1  2/473 (0.42%)  2
Complex partial seizures * 1  1/473 (0.21%)  1
Convulsion * 1  3/473 (0.63%)  3
Epilepsy * 1  10/473 (2.11%)  10
Grand mal convulsion * 1  1/473 (0.21%)  1
Haemorrhage intracranial * 1  1/473 (0.21%)  1
Headache * 1  1/473 (0.21%)  1
Hypoxic-ischaemic encephalopathy * 1  1/473 (0.21%)  1
Intracranial haematoma * 1  1/473 (0.21%)  1
Partial seizures with secondary generalisation * 1  1/473 (0.21%)  1
Seizure cluster * 1  1/473 (0.21%)  2
Status epilepticus * 1  11/473 (2.33%)  13
Subarachnoid haemorrhage * 1  2/473 (0.42%)  2
Temporal lobe epilepsy * 1  1/473 (0.21%)  1
Transient ischaemic attack * 1  1/473 (0.21%)  1
Visual field defect * 1  1/473 (0.21%)  1
Pregnancy, puerperium and perinatal conditions   
Abortion spontaneous * 1  1/473 (0.21%)  1
Pregnancy on contraceptive * 1  1/473 (0.21%)  1
Psychiatric disorders   
Epileptic psychosis * 1  3/473 (0.63%)  3
Hallucination * 1  1/473 (0.21%)  1
Mental disorder * 1  1/473 (0.21%)  1
Suicidal ideation * 1  1/473 (0.21%)  1
Suicide attempt * 1  1/473 (0.21%)  1
Renal and urinary disorders   
Renal impairment * 1  1/473 (0.21%)  1
Reproductive system and breast disorders   
Prostatitis * 1  1/473 (0.21%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma * 1  1/473 (0.21%)  1
Haemoptysis * 1  1/473 (0.21%)  1
Nasal septum deviation * 1  2/473 (0.42%)  2
Rhinitis allergic * 1  1/473 (0.21%)  1
Vocal cord leukoplakia * 1  1/473 (0.21%)  1
Surgical and medical procedures   
Abortion induced * 1  3/473 (0.63%)  3
Wisdom teeth removal * 1  2/473 (0.42%)  2
Vascular disorders   
Varicose vein * 1  1/473 (0.21%)  1
Venous occlusion * 1  1/473 (0.21%)  1
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide (SS)
Affected / at Risk (%) # Events
Total   343/473 (72.52%)    
Eye disorders   
Vision blurred * 1  22/473 (4.65%)  29
Gastrointestinal disorders   
Abdominal pain upper * 1  28/473 (5.92%)  57
Diarrhoea * 1  41/473 (8.67%)  64
Nausea * 1  30/473 (6.34%)  46
Toothache * 1  38/473 (8.03%)  47
Vomiting * 1  37/473 (7.82%)  66
General disorders   
Pyrexia * 1  41/473 (8.67%)  53
Infections and infestations   
Gastroenteritis * 1  27/473 (5.71%)  36
Nasopharyngitis * 1  156/473 (32.98%)  510
Pharyngitis * 1  22/473 (4.65%)  38
Upper respiratory tract infection * 1  99/473 (20.93%)  208
Injury, poisoning and procedural complications   
Contusion * 1  27/473 (5.71%)  37
Nervous system disorders   
Dizziness * 1  125/473 (26.43%)  318
Headache * 1  77/473 (16.28%)  177
Somnolence * 1  41/473 (8.67%)  80
Psychiatric disorders   
Insomnia * 1  26/473 (5.50%)  32
Respiratory, thoracic and mediastinal disorders   
Cough * 1  27/473 (5.71%)  43
Oropharyngeal pain * 1  27/473 (5.71%)  48
1
Term from vocabulary, MedDRA16.1
*
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: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT01832038    
Other Study ID Numbers: EP0009
First Submitted: March 28, 2013
First Posted: April 15, 2013
Results First Submitted: July 28, 2020
Results First Posted: August 13, 2020
Last Update Posted: August 17, 2021