Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)

• ClinicalTrials.gov Identifier: NCT00520741
• Recruitment Status: Completed
• First Posted: August 27, 2007
• Results First Posted: April 23, 2014
• Last Update Posted: July 19, 2018
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Lacosamide
• Enrollment: 426

Participant Flow

Recruitment Details	The study was conducted at 160 sites in the United States of America (USA), Canada, Europe, and Australia.The maximum duration of a subject's trial participation is 30 weeks. The Participant Flow refers to the Safety Set (SS) population which consists of all patients who received at least one dose of study medication.
Pre-assignment Details	Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Period Title: Overall Study
Started	106	319 [1]
Completed	69	194
Not Completed	37	125
Reason Not Completed
Adverse Event	16	56
Lack of Efficacy	11	30
Withdrawal by Subject	0	11
Protocol Violation	2	15
Unsatisfactory compliance of subject	4	3
Lost to Follow-up	4	4
Other reasons for premature termination	0	6
[1] One subject was randomized at 2 sites and excluded from the Safety Set.

Baseline Characteristics

Arm/Group Title		Lacosamide 300 mg/Day	Lacosamide 400 mg/Day	Total
Arm/Group Description		Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Total of all reporting groups
Overall Number of Baseline Participants		106	319	425
Baseline Analysis Population Description		The Baseline Analysis Population refers to the Safety Set (SS) which includes the unique randomized subjects who took at least one dose of study medication.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants	319 participants	425 participants
	<=18 years	3 2.8%	7 2.2%	10 2.4%
	Between 18 and 65 years	99 93.4%	303 95.0%	402 94.6%
	>=65 years	4 3.8%	9 2.8%	13 3.1%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	106 participants	319 participants	425 participants
		41.4 (14.3)	40.4 (12.5)	40.6 (13.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants	319 participants	425 participants
	Female	50 47.2%	169 53.0%	219 51.5%
	Male	56 52.8%	150 47.0%	206 48.5%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	106 participants	319 participants	425 participants
White		91	246	337
Black		9	53	62
Asian		0	1	1
Other		6	19	25
Height; Mean (Standard Deviation); Unit of measure: Centimeter
	Number Analyzed	106 participants	319 participants	425 participants
		169.72 (10.69)	169.01 (10.87)	169.19 (10.82)
Weight; Mean (Standard Deviation); Unit of measure: Kilogram
	Number Analyzed	106 participants	319 participants	425 participants
		81.62 (19.53)	82.13 (21.30)	82.00 (20.85)
Body Mass Index (BMI); Mean (Standard Deviation); Unit of measure: Kg/m^2
	Number Analyzed	106 participants	319 participants	425 participants
		28.22 (5.74)	28.67 (6.64)	28.56 (6.42)
Average Baseline Seizure Frequency per 28 days; Mean (Standard Deviation); Unit of measure: Seizures/28 days
	Number Analyzed	106 participants	319 participants	425 participants
		10.10 (8.82)	10.22 (8.88)	10.19 (8.86)

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s)
Description	Pre-defined exit criteria: A 2-fold or greater increase in average monthly (28-day) partial seizure frequency (motor and non-motor) compared to average monthly partial seizure frequency (motor and non-motor) during the Baseline Phase; A 2-fold or greater increase in consecutive 2-day partial seizure frequency (motor and non-motor) versus the highest consecutive 2-day partial seizure frequency (motor and non-motor) that occurred during the Baseline Phase. Note: if the highest consecutive 2-day partial seizure frequency during the Baseline Phase is 1, a 2-day partial seizure frequency of ≥3 is required to meet this exit criterion; Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization; A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation; Status epilepticus, or new onset of serial/cluster seizures
Time Frame	16 Weeks Maintenance Period (approximately 112 days)

Outcome Measure Data

Analysis Population Description

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (ie, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

The primary analysis is only conducted on the Lacosamide 400 mg/day group.

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description:	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Overall Number of Participants Analyzed	0	284
Measure Type: Number; Unit of Measure: percentage of subjects
		30

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lacosamide 400 mg/Day
	Comments	The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the lower bound of the 95 % prediction interval for the historical-control of 0.653; hereafter referred to as the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Kaplan-Meier
	Comments	Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.
Method of Estimation	Estimation Parameter	Predicted exit rate at 112 days
	Estimated Value	0.300
	Confidence Interval	(2-Sided) 95%; 0.246 to 0.355
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Time to First Occurrence of Any Exit Event During The Maintenance Period
Description	The time to first occurrence (days) of any exit event was estimated using Kaplan-Meier methods and was based on the time from the start of the Maintenance Phase to the earliest date a subject met an exit criterion. Subjects who discontinued during the Maintenance Phase due to non-exit criteria reasons or who completed the Maintenance Phase before 112 days and did not meet an exit criterion were censored as of the last Maintenance Phase dose date. Subjects completing 112 days in the Maintenance Phase were censored as of Day 112.
Time Frame	16 Weeks Maintenance Period (approximately 112 days)

Outcome Measure Data

Analysis Population Description

The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs). In addition to being a member of FAS, subjects also met at least one of the exit criterion noted under the Primary Outcome Measure.

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description:	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Overall Number of Participants Analyzed	26	82
Median (Full Range); Unit of Measure: days
	39; (1 to 80)	45.0; (3 to 102)

3. Secondary Outcome

Title	Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period
Description	Subjects were classified as having an exit event if they experienced at least 1 of the following events during the Maintenance Phase as of Day 112: Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis; Withdrawal due to AE with onset during the Maintenance Phase; Withdrew prematurely due to lack of efficacy during the Maintenance Phase The date the subject experienced the event was set to the earliest date the subject met an exit criterion or the date of the last Maintenance Phase dose for subjects not meeting an exit criterion but withdrawing due to an AE or lack of efficacy. The secondary analysis is only conducted on the Lacosamide 400 mg/day group.
Time Frame	16 Weeks Maintenance Period (approximately 112 days)

Outcome Measure Data

Analysis Population Description

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description:	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3 :1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure.
Overall Number of Participants Analyzed	0	284
Measure Type: Number; Unit of Measure: percentage of subjects
		32.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lacosamide 400 mg/Day
	Comments	The upper limit of the Confidence Interval for the estimate of the Lacosamide (LCM) 400 mg/day exit rate was compared with the historical-control exit rate. The LCM 400 mg/day dose group would be declared an effective conversion to monotherapy treatment if the upper 95 % confidence limit for the estimate of the exit rate was less than 0.653.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	[Not Specified]
	Comments	[Not Specified]
	Method	Kaplan-Meier
	Comments	Subjects who dropped out due to non-exit criteria reasons over the 10 % censoring maximum were to be counted as an exit.
Method of Estimation	Estimation Parameter	predicted exit rate at 112 days
	Estimated Value	0.323
	Confidence Interval	(2-Sided) 95%; 0.268 to 0.378
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12)
Description	Days on Monotherapy Treatment were defined as the number of days during the Monotherapy Phase when the subject took Lacosamide (LCM) only (ie, the total number of days exposed to LCM during the Monotherapy Phase minus any days where a concomitant or rescue Anti-epileptic Drug (AED) was taken by the subject). The days on Monotherapy Treatment did not need to be consecutive.
Time Frame	Visit 9 - Visit 12 (approximately 10 weeks)

Outcome Measure Data

Analysis Population Description

The Analysis Population refers to a subset of the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs).This subset of the FAS included subjects who entered the Maintenance Phase but who never achieved Lacosamide (LCM) monotherapy.

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description:	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Overall Number of Participants Analyzed	86	254
Median (Full Range); Unit of Measure: days
	71; (1 to 100)	71; (2 to 105)

5. Secondary Outcome

Title	Clinical Global Impression of Change (CGIC) From Baseline To Last Visit
Description	For the assessment of the Clinical Global Impression of Change (CGIC), the investigator should provide his/her assessment of the subject's clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status. He was asked the following:Please check the number that best describes the subject's condition over the past 4 weeks compared to Baseline: Very much improved; Much improved; Minimally improved; No change; Minimally worse; Much worse; Very much worse
Time Frame	Baseline; Last Visit (approximately 27 weeks)

Outcome Measure Data

Analysis Population Description

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description:	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Overall Number of Participants Analyzed	99	284
Measure Type: Number; Unit of Measure: participants
Very much improved	21	56
Much improved	33	116
Minimally improved	18	42
No change	8	18
Minimally worse	6	16
Much worse	8	23
Very much worse	1	1
Not done	4	12

6. Secondary Outcome

Title	Patient's Global Impression of Change (PGIC) From Baseline To Last Visit
Description	For the assessment of the Patient's Global Impression of Change, the subject should provide his/her assessment of his/her own clinical status, compared to Baseline, including an evaluation of seizure frequency and intensity, the occurrence of AEs, and subject's functional status.The subject was asked to answer the following: Over the past 4 weeks, how have you felt compared to before you entered this clinical trial? (Please check the number that best describes your condition.); Very much improved; Much improved; Minimally improved; No change; Minimally worse; Much worse; Very much worse
Time Frame	Baseline; Last Visit (approximately 27 weeks)

Outcome Measure Data

Analysis Population Description

The Analysis Population refers to the Full Analysis Set (FAS). The FAS included subjects who completed the Titration Phase and started withdrawing background Anti-epileptic Drugs (AEDs) (eg, entered the Maintenance Phase and took at least 1 dose of Maintenance medication).

Arm/Group Title	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
Arm/Group Description:	Lacosamide (LCM) 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.	Lacosamide (LCM) 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Overall Number of Participants Analyzed	99	284
Measure Type: Number; Unit of Measure: participants
Very much improved	24	81
Much improved	33	93
Minimally improved	15	37
No change	10	15
Minimally worse	3	19
Much worse	7	22
Very much worse	3	3
Not done	4	14

Adverse Events

Time Frame	Adverse Events (AEs) were collected from Baseline (week -8) up to the end of the study (week 22). Only Treatment-Emergent Adverse Events (TEAEs) are presented.
Adverse Event Reporting Description	Further detailed information about Sudden Unexplained Death in Epilepsy (SUDEP) is reported in the "Detailed Description" section.
Arm/Group Title	Lacosamide 300 mg/Day		Lacosamide 400 mg/Day
Arm/Group Description	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.		Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
All-Cause Mortality
	Lacosamide 300 mg/Day		Lacosamide 400 mg/Day
	Affected / at Risk (%)		Affected / at Risk (%)
Total	--/--		--/--
Serious Adverse Events
	Lacosamide 300 mg/Day		Lacosamide 400 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/106 (3.77%)		21/319 (6.58%)
Endocrine disorders
Inappropriate antidiuretic hormone secretion * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Gastrointestinal disorders
Food poisoning * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Gastrointestinal haemorrhage * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Glossitis * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
General disorders
Sudden unexplained death in epilepsy * 1	0/106 (0.00%)	0	2/319 (0.63%)	2
Immune system disorders
Hypersensitivity * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Injury, poisoning and procedural complications
Limb injury * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Polytraumatism * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Subdural haematoma * 1	1/106 (0.94%)	1	0/319 (0.00%)	0
Metabolism and nutrition disorders
Dehydration * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Nervous system disorders
Convulsion * 1	1/106 (0.94%)	1	6/319 (1.88%)	6
Epilepsy * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Headache * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Status epilepticus * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Subarachnoid haemorrhage * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Toxic induced encephalopathy * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Psychiatric disorders
Abnormal behaviour * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Conversion disorder * 1	1/106 (0.94%)	1	0/319 (0.00%)	0
Hallucination, auditory * 1	1/106 (0.94%)	1	0/319 (0.00%)	0
Hallucination, visual * 1	1/106 (0.94%)	1	0/319 (0.00%)	0
Psychotic disorder * 1	1/106 (0.94%)	1	0/319 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
Respiratory failure * 1	0/106 (0.00%)	0	1/319 (0.31%)	2
Skin and subcutaneous tissue disorders
Drug eruption * 1	0/106 (0.00%)	0	1/319 (0.31%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 9.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lacosamide 300 mg/Day		Lacosamide 400 mg/Day
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	74/106 (69.81%)		215/319 (67.40%)
Eye disorders
Vision blurred * 1	6/106 (5.66%)	6	19/319 (5.96%)	25
Gastrointestinal disorders
Nausea * 1	13/106 (12.26%)	16	46/319 (14.42%)	57
Diarrhoea * 1	7/106 (6.60%)	9	21/319 (6.58%)	22
Vomiting * 1	2/106 (1.89%)	2	23/319 (7.21%)	27
General disorders
Fatigue * 1	12/106 (11.32%)	14	32/319 (10.03%)	37
Infections and infestations
Nasopharyngitis * 1	7/106 (6.60%)	8	28/319 (8.78%)	30
Upper respiratory tract infection * 1	5/106 (4.72%)	6	16/319 (5.02%)	19
Musculoskeletal and connective tissue disorders
Back pain * 1	9/106 (8.49%)	9	11/319 (3.45%)	13
Nervous system disorders
Dizziness * 1	19/106 (17.92%)	26	86/319 (26.96%)	121
Headache * 1	21/106 (19.81%)	32	45/319 (14.11%)	58
Convulsion * 1	17/106 (16.04%)	22	29/319 (9.09%)	36
Somnolence * 1	15/106 (14.15%)	19	29/319 (9.09%)	35
Tremor * 1	8/106 (7.55%)	8	23/319 (7.21%)	23
Cognitive disorder * 1	7/106 (6.60%)	8	6/319 (1.88%)	6
Psychiatric disorders
Insomnia * 1	8/106 (7.55%)	10	17/319 (5.33%)	17
Anxiety * 1	7/106 (6.60%)	8	11/319 (3.45%)	13
Skin and subcutaneous tissue disorders
Rash * 1	4/106 (3.77%)	5	16/319 (5.02%)	20
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA 9.1

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: UCB Clinical Trial Call Center
• Organization: UCB
• Phone: +1 877 822 9493

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.

• Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
• ClinicalTrials.gov Identifier: NCT00520741
• Obsolete Identifiers: NCT01058954
• Other Study ID Numbers: SP0902; 2007-005439-27 ( EudraCT Number )
• First Submitted: August 24, 2007
• First Posted: August 27, 2007
• Results First Submitted: November 26, 2013
• Results First Posted: April 23, 2014
• Last Update Posted: July 19, 2018