Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures (NCT NCT01832038)
NCT ID: NCT01832038
Last Updated: 2021-08-17
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
473 participants
Primary outcome timeframe
From Visit 1 (Week 0) up to approximately Week 323
Results posted on
2021-08-17
Participant Flow
The study started to enroll participants in March 2013 and concluded in July 2019.
Participant Flow refers to the Safety Set.
Participant milestones
| Measure |
Lacosamide
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 Study
STARTED
|
473
|
|
Overall Study
COMPLETED
|
238
|
|
Overall Study
NOT COMPLETED
|
235
|
Reasons for withdrawal
| Measure |
Lacosamide
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 Study
Death
|
5
|
|
Overall Study
Adverse Event
|
50
|
|
Overall Study
Lack of Efficacy
|
81
|
|
Overall Study
Protocol Violation
|
7
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Withdrawal by Subject
|
49
|
|
Overall Study
Visit non-compliance
|
2
|
|
Overall Study
Subject refused to return visit
|
2
|
|
Overall Study
Not convenient to come back to site
|
2
|
|
Overall Study
Participant was asked to quit
|
5
|
|
Overall Study
Back home
|
1
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Low compliance
|
3
|
|
Overall Study
Prohibit procedure
|
2
|
|
Overall Study
Not possible to visit the hospital
|
1
|
|
Overall Study
Changes of implementation system
|
3
|
|
Overall Study
Plan to pregnancy
|
7
|
|
Overall Study
Bad mood and has suicidal thought
|
1
|
|
Overall Study
Prohibited concomitant medication
|
1
|
|
Overall Study
Pregnancy and abortion in EP0008 study
|
1
|
|
Overall Study
Subject considered the efficacy was poor
|
1
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, and Efficacy of Long-term Adjunctive Therapy With Lacosamide in Adults With Partial-onset Seizures
Baseline characteristics by cohort
| Measure |
Lacosamide
n=473 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
39 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
432 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
32.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
259 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
214 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
350 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
123 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) up to approximately Week 323Population: The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.
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.
Outcome measures
| Measure |
Lacosamide (SS)
n=473 Participants
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).
|
|---|---|
|
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
|
410 Participants
|
PRIMARY outcome
Timeframe: From Visit 1 (Week 0) up to approximately Week 323Population: The Safety Set (SS) included all enrolled participants in EP0009 who took at least 1 dose of LCM in EP0009.
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.
Outcome measures
| Measure |
Lacosamide (SS)
n=473 Participants
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).
|
|---|---|
|
Number of Participants That Withdrew Due to Adverse Events From Baseline Until the End of Study Visit
|
51 Participants
|
SECONDARY outcome
Timeframe: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009Population: 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.
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 \[NCT01710657\].
Outcome measures
| Measure |
Lacosamide (SS)
n=471 Participants
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).
|
|---|---|
|
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
|
-44.47 Percent change
Standard Deviation 55.82
|
SECONDARY outcome
Timeframe: From Visit 1 in study EP0008 [NCT01710657] up to approximately Week 323 in study EP0009Population: 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.
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 \[NCT01710657\].
Outcome measures
| Measure |
Lacosamide (SS)
n=471 Participants
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).
|
|---|---|
|
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
|
57.1 percentage of participants
|
Adverse Events
Lacosamide (SS)
Serious events: 83 serious events
Other events: 343 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Lacosamide (SS)
n=473 participants at risk
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).
|
|---|---|
|
Cardiac disorders
Sinus bradycardia
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Congenital, familial and genetic disorders
Hamartoma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Eye disorders
Blindness unilateral
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Duodenitis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Dyspepsia
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Gastritis
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.21%
1/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Hypertrophic anal papilla
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Rectal polyp
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
General disorders
Pyrexia
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
General disorders
Sudden death
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Hepatobiliary disorders
Cholecystitis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Bacterial prostatitis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Chronic sinusitis
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Encephalitis viral
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Erysipelas
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Lung infection
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Orchitis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Peritonitis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Peritonsillar abscess
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Pneumonia
|
1.3%
6/473 • Number of events 6 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Retroperitoneal infection
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Tuberculosis of genitourinary system
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Upper respiratory tract infection
|
0.42%
2/473 • Number of events 3 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Brain contusion
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Face injury
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.42%
2/473 • Number of events 3 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.21%
1/473 • Number of events 3 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Head injury
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Injury
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.21%
1/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.21%
1/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meigs' syndrome
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic glioma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Cerebral infarction
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Complex partial seizures
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Convulsion
|
0.63%
3/473 • Number of events 3 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Epilepsy
|
2.1%
10/473 • Number of events 10 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Grand mal convulsion
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Headache
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Intracranial haematoma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Partial seizures with secondary generalisation
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Seizure cluster
|
0.21%
1/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Status epilepticus
|
2.3%
11/473 • Number of events 13 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Temporal lobe epilepsy
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Transient ischaemic attack
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Visual field defect
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy on contraceptive
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Psychiatric disorders
Epileptic psychosis
|
0.63%
3/473 • Number of events 3 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Psychiatric disorders
Hallucination
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Psychiatric disorders
Mental disorder
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Psychiatric disorders
Suicidal ideation
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Psychiatric disorders
Suicide attempt
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Renal and urinary disorders
Renal impairment
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Reproductive system and breast disorders
Prostatitis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord leukoplakia
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Surgical and medical procedures
Abortion induced
|
0.63%
3/473 • Number of events 3 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.42%
2/473 • Number of events 2 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Vascular disorders
Varicose vein
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Vascular disorders
Venous occlusion
|
0.21%
1/473 • Number of events 1 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
Other adverse events
| Measure |
Lacosamide (SS)
n=473 participants at risk
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).
|
|---|---|
|
Eye disorders
Vision blurred
|
4.7%
22/473 • Number of events 29 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
28/473 • Number of events 57 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Diarrhoea
|
8.7%
41/473 • Number of events 64 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Nausea
|
6.3%
30/473 • Number of events 46 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Toothache
|
8.0%
38/473 • Number of events 47 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
37/473 • Number of events 66 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
General disorders
Pyrexia
|
8.7%
41/473 • Number of events 53 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Gastroenteritis
|
5.7%
27/473 • Number of events 36 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Nasopharyngitis
|
33.0%
156/473 • Number of events 510 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Pharyngitis
|
4.7%
22/473 • Number of events 38 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Infections and infestations
Upper respiratory tract infection
|
20.9%
99/473 • Number of events 208 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Injury, poisoning and procedural complications
Contusion
|
5.7%
27/473 • Number of events 37 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Dizziness
|
26.4%
125/473 • Number of events 318 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Headache
|
16.3%
77/473 • Number of events 177 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Nervous system disorders
Somnolence
|
8.7%
41/473 • Number of events 80 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Psychiatric disorders
Insomnia
|
5.5%
26/473 • Number of events 32 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.7%
27/473 • Number of events 43 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
27/473 • Number of events 48 • Adverse Events were collected from Visit 1 (Week 0) up to approximately Week 323
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60