To Determine Tolerability and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00552305
• Collaborator: (none)
• Enrollment: 370
• Locations: 59
• Arm: 1
• Duration (Months): 102
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy.

Condition or Disease	Intervention/Treatment	Phase
Partial Epilepsies	Drug: lacosamide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 370 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Extension Trial to Determine Tolerability and Efficacy of Long-term Oral SPM 927 as Adjunctive Therapy in Patients With Partial Seizures
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Feb 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lacosamide 50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing	Drug: lacosamide; 50mg and 100mg tablets up to 800 mg/day as twice a day (BID) dosing throughout the trial; Other Names: Vimpat

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) [During the Treatment Period (up to 8 years)]

   Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

2. Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years) [During the Treatment Period (up to 8 years)]

   Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

3. Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years) [During the Treatment Period (up to 8 years)]

   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.

Secondary Outcome Measures

1. Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years) [Baseline, End of Treatment Period (up to 8 years)]

   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.

2. Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years) [Treatment Period (up to 8 years)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Completion of parent clinical trial for treatment of partial seizures.

Exclusion Criteria:

• Receiving any study drug or experimental device other than lacosamide.

• Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Huntsville	Alabama	United States
3		Phoenix	Arizona	United States
4		Tucson	Arizona	United States
5		Little Rock	Arkansas	United States
6		Los Angeles	California	United States
7		Englewood	Colorado	United States
8		Gainesville	Florida	United States
9		Hollywood	Florida	United States
10		Miami	Florida	United States
11		Ponte Vedra Beach	Florida	United States
12		Chicago	Illinois	United States
13		Springfield	Illinois	United States
14		Indianapolis	Indiana	United States
15		Iowa City	Iowa	United States
16		Wichita	Kansas	United States
17		Crestview Hills	Kentucky	United States
18		Lexington	Kentucky	United States
19		Baltimore	Maryland	United States
20		Frederick	Maryland	United States
21		Boston	Massachusetts	United States
22		Ann Arbor	Michigan	United States
23		Detroit	Michigan	United States
24		Saint Paul	Minnesota	United States
25		Chesterfield	Missouri	United States
26		Saint Louis	Missouri	United States
27		Somerset	New Jersey	United States
28		New York	New York	United States
29		Durham	North Carolina	United States
30		Cincinnati	Ohio	United States
31		Cleveland	Ohio	United States
32		Columbus	Ohio	United States
33		Hershey	Pennsylvania	United States
34		Philadelphia	Pennsylvania	United States
35		Nashville	Tennessee	United States
36		Dallas	Texas	United States
37		Irving	Texas	United States
38		Lubbock	Texas	United States
39		Wichita Falls	Texas	United States
40		Bennington	Vermont	United States
41		Charlottesville	Virginia	United States
42		Marshfield	Wisconsin	United States
43		Milwaukee	Wisconsin	United States
44		Bonn		Germany
45		Erlangen		Germany
46		Kehl Kork		Germany
47		Schwalmstedt-Treysa		Germany
48		Budapest		Hungary
49		Zalaegerszeg		Hungary
50		Kaunas		Lithuania
51		Vilnius		Lithuania
52		Poznan		Poland
53		Goteborg		Sweden
54		Stockholm		Sweden
55		Bern/Biel		Switzerland
56		Zurich		Switzerland
57		Bucks/London		United Kingdom
58		Glasgow		United Kingdom
59		Liverpool		United Kingdom

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Product Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00552305
• Other Study ID Numbers: SP0615
• First Posted: Nov 1, 2007
• Last Update Posted: Jul 17, 2018
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Seizures; Epilepsies, Partial; Lacosamide

Study Results

Participant Flow

Recruitment Details	The study was started in August of 2001 with recruitment occurring in the United States, Germany, Hungary, Lithuania, Poland, Sweden, Switzerland, and the United Kingdom. The study had last patient last visit in February of 2010.

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Period Title: Overall Study
STARTED	370
COMPLETED	120
NOT COMPLETED	250

Baseline Characteristics

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Overall Participants	370
Age (Count of Participants)
<=18 years	3 0.8%
Between 18 and 65 years	364 98.4%
>=65 years	3 0.8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	40.8 (11.01)
Sex: Female, Male (Count of Participants)
Female	192 51.9%
Male	178 48.1%
Region of Enrollment (participants) [Number]
United States	248 67%
Hungary	13 3.5%
Poland	4 1.1%
Lithuania	46 12.4%
Germany	21 5.7%
United Kingdom	12 3.2%
Switzerland	2 0.5%
Sweden	24 6.5%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Treat-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
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 8 years)

Outcome Measure Data

Analysis Population Description

Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Measure Participants	370
Number [subjects]	343

2. Primary Outcome

Title	Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (up to 8 Years)
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 8 years)

Outcome Measure Data

Analysis Population Description

Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Measure Participants	370
Number [subjects]	47

3. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 8 Years)
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 8 years)

Outcome Measure Data

Analysis Population Description

Of the 370 subjects who entered the study, 370 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Measure Participants	370
Number [subjects]	125

4. Secondary Outcome

Title	Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 8 Years)
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, End of Treatment Period (up to 8 years)

Outcome Measure Data

Analysis Population Description

Of the 370 subjects who were enrolled/treated in the study, 369 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 SP615 study.

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Measure Participants	369
Median (Full Range) [percentage change]	-50.8

5. Secondary Outcome

Title	Percentage of at Least 50% Responders During the Treatment Period (up to 8 Years)
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 8 years)

Outcome Measure Data

Analysis Population Description

Of the 370 subjects who were enrolled/treated in the study, 369 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 SP615 study.

Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
Measure Participants	369
Number [percentage of subjects]	51.2

Adverse Events

Time Frame	The adverse event summaries are based on data collected during the 8 years of the study for all 370 patients
Arm/Group Title	Lacosamide
Arm/Group Description	50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
All Cause Mortality
	Lacosamide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	125/370 (33.8%)
Blood and lymphatic system disorders
LEUKOPENIA	1/370 (0.3%)	1
Cardiac disorders
SINUS BRADYCARDIA	3/370 (0.8%)	3
ANGINA PECTORIS	3/370 (0.8%)	3
ATRIAL FIBRILLATION	1/370 (0.3%)	1
ATRIOVENTRICULAR BLOCK FIRST DEGREE	1/370 (0.3%)	1
ACUTE CORONARY SYNDROME	1/370 (0.3%)	1
BRADYCARDIA	1/370 (0.3%)	1
CARDIAC FIBRILLATION	1/370 (0.3%)	1
CARDIOMYOPATHY	1/370 (0.3%)	1
CORONARY ARTERY STENOSIS	1/370 (0.3%)	1
CORONARY ARTERY DISEASE	1/370 (0.3%)	1
MYOCARDIAL INFARCTION	1/370 (0.3%)	1
Ear and labyrinth disorders
VERTIGO	1/370 (0.3%)	1
Eye disorders
VISION BLURRED	1/370 (0.3%)	1
Gastrointestinal disorders
VOMITING	2/370 (0.5%)	3
COLITIS	1/370 (0.3%)	1
INGUINAL HERNIA	1/370 (0.3%)	1
HAEMORRHOIDS	1/370 (0.3%)	1
IRRITABLE BOWEL SYNDROME	1/370 (0.3%)	1
NAUSEA	1/370 (0.3%)	1
RECTAL HAEMORRHAGE	1/370 (0.3%)	1
COLONIC POLYP	1/370 (0.3%)	1
ABDOMINAL PAIN	1/370 (0.3%)	1
DIARRHOEA	1/370 (0.3%)	1
ILEUS	1/370 (0.3%)	2
ENTEROCELE	1/370 (0.3%)	1
General disorders
CHEST PAIN	5/370 (1.4%)	6
NON-CARDIAC CHEST PAIN	4/370 (1.1%)	4
OEDEMA PERIPHERAL	1/370 (0.3%)	1
IRRITABILITY	1/370 (0.3%)	1
Hepatobiliary disorders
CHOLELITHIASIS	1/370 (0.3%)	1
Infections and infestations
PNEUMONIA	2/370 (0.5%)	2
BRONCHITIS	1/370 (0.3%)	1
APPENDICITIS	1/370 (0.3%)	1
BACTERIAL INFECTION	1/370 (0.3%)	1
GASTROINTESTINAL INFECTION	1/370 (0.3%)	1
URINARY TRACT INFECTION	1/370 (0.3%)	1
Injury, poisoning and procedural complications
HAND FRACTURE	3/370 (0.8%)	3
DRUG TOXICITY	3/370 (0.8%)	3
ANKLE FRACTURE	2/370 (0.5%)	2
INJURY	2/370 (0.5%)	2
HEAD INJURY	2/370 (0.5%)	2
INTENTIONAL OVERDOSE	2/370 (0.5%)	2
CEREBRAL HAEMORRHAGE TRAUMATIC	1/370 (0.3%)	1
FALL	1/370 (0.3%)	1
PELVIC FRACTURE	1/370 (0.3%)	1
POST-TRAUMATIC PAIN	1/370 (0.3%)	1
TREATMENT NONCOMPLIANCE	1/370 (0.3%)	1
UPPER LIMB FRACTURE	1/370 (0.3%)	1
CERVICAL VERTEBRAL FRACTURE	1/370 (0.3%)	1
LOWER LIMB FRACTURE	1/370 (0.3%)	1
OVERDOSE	1/370 (0.3%)	1
PNEUMOTHORAX TRAUMATIC	1/370 (0.3%)	1
RIB FRACTURE	1/370 (0.3%)	1
ROAD TRAFFIC ACCIDENT	1/370 (0.3%)	1
THORACIC VERTEBRAL FRACTURE	1/370 (0.3%)	1
TIBIA FRACTURE	1/370 (0.3%)	1
HIP FRACTURE	1/370 (0.3%)	2
MEDICAL DEVICE COMPLICATION	1/370 (0.3%)	1
SPINAL FRACTURE	1/370 (0.3%)	1
THERMAL BURN	1/370 (0.3%)	1
JOINT INJURY	1/370 (0.3%)	1
THERAPEUTIC AGENT TOXICITY	1/370 (0.3%)	1
Investigations
ELECTROENCEPHALOGRAM	4/370 (1.1%)	4
ELECTROCARDIOGRAM QRS COMPLEX PROLONGED	2/370 (0.5%)	2
BIOPSY	1/370 (0.3%)	1
INVESTIGATION	1/370 (0.3%)	1
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	1/370 (0.3%)	1
SINGLE PHOTON EMISSION COMPUTERISED TOMOGRAM	1/370 (0.3%)	1
BLOOD CREATINE PHOSPHOKINASE INCREASED	1/370 (0.3%)	1
ELECTROCARDIOGRAM CHANGE	1/370 (0.3%)	1
HEART RATE INCREASED	1/370 (0.3%)	1
URINARY CASTS	1/370 (0.3%)	1
Metabolism and nutrition disorders
DEHYDRATION	2/370 (0.5%)	3
HYPONATRAEMIA	2/370 (0.5%)	2
HYPOCALCAEMIA	1/370 (0.3%)	1
HYPERCALCAEMIA	1/370 (0.3%)	1
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION	3/370 (0.8%)	4
FLANK PAIN	2/370 (0.5%)	3
OSTEOARTHRITIS	2/370 (0.5%)	3
MUSCULOSKELETAL PAIN	1/370 (0.3%)	1
MUSCULAR WEAKNESS	1/370 (0.3%)	1
ARTHRITIS	1/370 (0.3%)	1
SPINAL COLUMN STENOSIS	1/370 (0.3%)	1
LUMBAR SPINAL STENOSIS	1/370 (0.3%)	1
ARTHRALGIA	1/370 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA	1/370 (0.3%)	1
HEPATIC NEOPLASM	1/370 (0.3%)	1
HAEMANGIOMA	1/370 (0.3%)	1
NEOPLASM	1/370 (0.3%)	1
SQUAMOUS CELL CARCINOMA	1/370 (0.3%)	1
GLIOBLASTOMA MULTIFORME	1/370 (0.3%)	1
THYROID NEOPLASM	1/370 (0.3%)	1
BREAST CANCER	1/370 (0.3%)	1
OVARIAN CANCER	1/370 (0.3%)	1
COLON NEOPLASM	1/370 (0.3%)	1
Nervous system disorders
CONVULSION	23/370 (6.2%)	26
STATUS EPILEPTICUS	7/370 (1.9%)	7
TRANSIENT ISCHAEMIC ATTACK	4/370 (1.1%)	5
HEADACHE	3/370 (0.8%)	3
HEMIPARESIS	2/370 (0.5%)	2
DIZZINESS	2/370 (0.5%)	2
GRAND MAL CONVULSION	2/370 (0.5%)	2
CEREBRAL INFARCTION	2/370 (0.5%)	2
EPILEPSY	2/370 (0.5%)	2
ENCEPHALOPATHY	1/370 (0.3%)	1
PARTIAL SEIZURES WITH SECONDARY GENERALISATION	1/370 (0.3%)	1
CEREBRAL HAEMORRHAGE	1/370 (0.3%)	1
METABOLIC ENCEPHALOPATHY	1/370 (0.3%)	1
MYASTHENIA GRAVIS	1/370 (0.3%)	1
MYASTHENIA GRAVIS CRISIS	1/370 (0.3%)	1
SYNCOPE	1/370 (0.3%)	1
COGNITIVE DISORDER	1/370 (0.3%)	1
CEREBROVASCULAR ACCIDENT	1/370 (0.3%)	1
COORDINATION ABNORMAL	1/370 (0.3%)	1
BALANCE DISORDER	1/370 (0.3%)	2
PSYCHOMOTOR HYPERACTIVITY	1/370 (0.3%)	1
OPTIC NEURITIS RETROBULBAR	1/370 (0.3%)	1
COMPLEX PARTIAL SEIZURES	1/370 (0.3%)	1
Pregnancy, puerperium and perinatal conditions
PREGNANCY	1/370 (0.3%)	1
Psychiatric disorders
CONFUSIONAL STATE	4/370 (1.1%)	4
DEPRESSION	3/370 (0.8%)	3
MAJOR DEPRESSION	2/370 (0.5%)	2
AGGRESSION	2/370 (0.5%)	2
SUICIDAL IDEATION	2/370 (0.5%)	2
EPILEPTIC PSYCHOSIS	1/370 (0.3%)	2
HALLUCINATION	1/370 (0.3%)	1
PARANOIA	1/370 (0.3%)	1
SUICIDE ATTEMPT	1/370 (0.3%)	1
ACUTE PSYCHOSIS	1/370 (0.3%)	2
HALLUCINATION, AUDITORY	1/370 (0.3%)	1
NIGHTMARE	1/370 (0.3%)	1
Renal and urinary disorders
NEPHROLITHIASIS	2/370 (0.5%)	2
RENAL FAILURE ACUTE	1/370 (0.3%)	1
HAEMATURIA	1/370 (0.3%)	1
PROTEINURIA	1/370 (0.3%)	1
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING	1/370 (0.3%)	1
UTERINE HAEMORRHAGE	1/370 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	2/370 (0.5%)	2
PULMONARY FIBROSIS	1/370 (0.3%)	1
RESPIRATORY FAILURE	1/370 (0.3%)	1
ASPHYXIA	1/370 (0.3%)	1
ASTHMA	1/370 (0.3%)	8
PNEUMOTHORAX	1/370 (0.3%)	1
ACUTE RESPIRATORY FAILURE	1/370 (0.3%)	1
Skin and subcutaneous tissue disorders
RASH	1/370 (0.3%)	1
Surgical and medical procedures
ABORTION INDUCED	2/370 (0.5%)	2
THERAPY REGIMEN CHANGED	1/370 (0.3%)	1
BRAIN OPERATION	1/370 (0.3%)	1
HYSTERECTOMY	1/370 (0.3%)	1
SURGERY	1/370 (0.3%)	1
BRAIN LOBECTOMY	1/370 (0.3%)	1
STENT PLACEMENT	1/370 (0.3%)	1
VAGAL NERVE STIMULATOR REMOVAL	1/370 (0.3%)	1
NASAL SEPTAL OPERATION	1/370 (0.3%)	1
Vascular disorders
DEEP VEIN THROMBOSIS	2/370 (0.5%)	2
CIRCULATORY COLLAPSE	1/370 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	307/370 (83%)
Eye disorders
DIPLOPIA	63/370 (17%)	92
VISION BLURRED	47/370 (12.7%)	60
Gastrointestinal disorders
NAUSEA	64/370 (17.3%)	89
VOMITING	49/370 (13.2%)	71
DIARRHOEA	29/370 (7.8%)	40
CONSTIPATION	20/370 (5.4%)	21
General disorders
FATIGUE	61/370 (16.5%)	77
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	61/370 (16.5%)	108
NASOPHARYNGITIS	60/370 (16.2%)	111
SINUSITIS	43/370 (11.6%)	62
INFLUENZA	32/370 (8.6%)	42
URINARY TRACT INFECTION	31/370 (8.4%)	48
BRONCHITIS	28/370 (7.6%)	34
Injury, poisoning and procedural complications
CONTUSION	57/370 (15.4%)	129
SKIN LACERATION	50/370 (13.5%)	117
EXCORIATION	27/370 (7.3%)	50
JOINT SPRAIN	19/370 (5.1%)	23
Investigations
WEIGHT INCREASED	21/370 (5.7%)	22
Musculoskeletal and connective tissue disorders
BACK PAIN	43/370 (11.6%)	63
PAIN IN EXTREMITY	33/370 (8.9%)	49
ARTHRALGIA	31/370 (8.4%)	42
MUSCULOSKELETAL PAIN	21/370 (5.7%)	30
MUSCULAR WEAKNESS	20/370 (5.4%)	24
Nervous system disorders
DIZZINESS	147/370 (39.7%)	254
HEADACHE	77/370 (20.8%)	145
COORDINATION ABNORMAL	53/370 (14.3%)	69
SOMNOLENCE	41/370 (11.1%)	50
TREMOR	39/370 (10.5%)	55
MEMORY IMPAIRMENT	27/370 (7.3%)	29
CONVULSION	27/370 (7.3%)	32
BALANCE DISORDER	26/370 (7%)	34
NYSTAGMUS	24/370 (6.5%)	28
HYPOAESTHESIA	20/370 (5.4%)	26
Psychiatric disorders
INSOMNIA	33/370 (8.9%)	35
DEPRESSION	33/370 (8.9%)	36
ANXIETY	19/370 (5.1%)	20
Respiratory, thoracic and mediastinal disorders
COUGH	29/370 (7.8%)	33
PHARYNGOLARYNGEAL PAIN	26/370 (7%)	34
Skin and subcutaneous tissue disorders
RASH	28/370 (7.6%)	33
Vascular disorders
HYPERTENSION	19/370 (5.1%)	19

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.