Evaluating Long Term Safety of Lacosamide (LCM) to Carbam... | NCT01465997

NCT01465997

ID	Type	Description	Link
2010-021238-74	EudraCT Number

Status Module

Name	Class
Eden Sarl	INDUSTRY

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lacosamide	Experimental	50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)	Drug: Lacosamide
Carbamazepine-Controlled Release (CBZ-CR)	Active Comparator	200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years)	Drug: Carbamazepine-Controlled Release (CBZ-CR)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lacosamide	Drug	50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)	Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.	Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)	Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.	Up to 3.5 Years (Duration of the Treatment Phase)
Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)	A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.	Up to 3.5 Years (Duration of the Treatment Phase)

Eligibility Module

Name	Affiliation	Role
UCB Cares	+1 877 822 9493 (UCB)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
786		Alabaster	Alabama		United States
799

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34265173	Derived	Ben-Menachem E, Dominguez J, Szasz J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.

Label	URL
FDA Safety Alerts and Recalls	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Lacosamide	50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
FG001	Carbamazepine-Controlled Release (CBZ-CR)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Lacosamide	50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
BG001	Carbamazepine-Controlled Release (CBZ-CR)	200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.
BG002	Total Title

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0008 BG0018 BG00216
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00043.2± 17.2 BG00142.7± 16.7 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000125 BG001125 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Subjects With at Least One Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum of 3.5 Years)

Treatment-emergent AEs were defined as those events which started on or after the date of first dose of SP0994 study medication, or events in which severity worsened on or after the date of first dose of SP0994 study medication. AEs which occurred within 30 days after last dose of study medication were considered treatment emergent.

Posted

Count of Participants

Participants

Up to 3.5 Years (Duration of the Treatment Phase)

ID	Title	Description
OG000	Lacosamide (SS)	50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
OG001	Carbamazepine-Controlled Release (CBZ-CR) (SS)	200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

Units	Counts
Participants	OG000279 OG001269

Title

Denominators

Categories

Title	Measurements
	OG000181 OG001182

Primary

Number of Subjects Who Withdrew From the Study Due to a Treatment-emergent Adverse Event (AE) During the Treatment Phase (Maximum 3.5 Years)

Posted

Count of Participants

Participants

Up to 3.5 Years (Duration of the Treatment Phase)

ID	Title	Description
OG000	Lacosamide	50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
OG001	Carbamazepine-Controlled Release (CBZ-CR)	200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

Units	Counts
Participants

Primary

Number of Subjects With at Least One Treatment-emergent Serious Adverse Event (SAE) During the Treatment Phase (Maximum of 3.5 Years)

A Serious Adverse Event is any untoward medical occurrence that at any dose results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity is a congenital anomaly/birth defect.

Posted

Count of Participants

Participants

Up to 3.5 Years (Duration of the Treatment Phase)

ID	Title	Description
OG000	Lacosamide	50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.
OG001	Carbamazepine-Controlled Release (CBZ-CR)	200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Lacosamide (SS)	50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding.			32	279	45	279
EG001	Carbamazepine-Controlled Release (CBZ-CR) (SS)	200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding.			22	269	42	269

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Eosinophilia	Blood and lymphatic system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Angina pectoris	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected279 at risk EG0010 events0 affected269 at risk
Atrial fibrillation	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0011 events1 affected269 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Cardiac failure	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Vestibular ataxia	Ear and labyrinth disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Exophthalmos	Eye disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Appendicitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Gastroenteritis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0014 events3 affected269 at risk
Post procedural infection	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0011 events1 affected269 at risk
Fall	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected279 at risk EG0010 events0 affected269 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Hepatic enzyme increased	Investigations	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected279 at risk EG0011 events1 affected269 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events1 affected279 at risk EG0010 events0 affected269 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Benign breast neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0002 events2 affected279 at risk EG0010 events0 affected269 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Cognitive disorder	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Grand mal convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Ischaemic stroke	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Status epilepticus	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Syncope	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
White matter lesion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Convulsion	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Hemiparesis	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Pregnancy on contraceptive	Pregnancy, puerperium and perinatal conditions	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0012 events2 affected269 at risk
Suicidal ideation	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0012 events2 affected269 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Suicidal behaviour	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Suicide attempt	Psychiatric disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0012 events2 affected269 at risk
Renal failure acute	Renal and urinary disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA16.1	Non-systematic Assessment	EG0000 events0 affected279 at risk EG0011 events1 affected269 at risk
Hypertension	Vascular disorders	MedDRA16.1	Non-systematic Assessment	EG0001 events1 affected279 at risk EG0010 events0 affected269 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA16.1	Non-systematic Assessment	EG00040 events20 affected279 at risk EG00122 events16 affected269 at risk
Headache	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00028 events17 affected279 at risk EG00126 events16 affected269 at risk
Dizziness	Nervous system disorders	MedDRA16.1	Non-systematic Assessment	EG00013 events12 affected279 at risk EG00119 events17 affected269 at risk

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144	Acids, Acyclic
D002264	Carboxylic Acids