Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00520741
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00520741
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : April 23, 2014
Last Update Posted : July 19, 2018
Sponsor:
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
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
Hide 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.
Arm/Group Title Lacosamide 300 mg/Day Lacosamide 400 mg/Day Total
Hide 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
Hide 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)
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)
Hide Description

Pre-defined exit criteria:

  1. 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
  2. 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

  3. Occurrence of a single generalized tonic-clonic seizure if none had occurred in the 6 months prior to randomization
  4. A prolongation or worsening of overall seizure duration, frequency, type or pattern considered by the investigator as serious enough to warrant trial discontinuation
  5. Status epilepticus, or new onset of serial/cluster seizures
Time Frame 16 Weeks Maintenance Period (approximately 112 days)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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:

  1. Met at least 1 exit criterion based on the calculations applied for the Primary Efficacy Analysis
  2. Withdrawal due to AE with onset during the Maintenance Phase
  3. 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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)
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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:

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Time Frame Baseline; Last Visit (approximately 27 weeks)
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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.)

  1. Very much improved
  2. Much improved
  3. Minimally improved
  4. No change
  5. Minimally worse
  6. Much worse
  7. Very much worse
Time Frame Baseline; Last Visit (approximately 27 weeks)
Hide Outcome Measure Data
Hide 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
Hide 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
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
Hide 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   --/--      --/--    
Hide 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
Hide 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
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
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