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Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT00655551
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : October 20, 2010
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Partial Epilepsies
Partial Onset Seizures
Intervention Drug: lacosamide
Enrollment 100

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Hide Arm/Group Description Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Period Title: All Periods Combined
Started 25 50 25
Completed 25 47 21
Not Completed 0 3 4
Reason Not Completed
Adverse Event             0             3             4
Period Title: Period 1 (up to 7 Days)
Started 25 0 0
Completed 25 0 0
Not Completed 0 0 0
Period Title: Period 2 (up to 7 Days)
Started 0 25 0
Completed 0 24 0
Not Completed 0 1 0
Reason Not Completed
Adverse Event             0             1             0
Period Title: Period 3 (up to 7 Days)
Started 0 0 25
Completed 0 0 21
Not Completed 0 0 4
Reason Not Completed
Adverse Event             0             0             4
Period Title: Period 4 (up to 7 Days)
Started 0 25 0
Completed 0 23 0
Not Completed 0 2 0
Reason Not Completed
Adverse Event             0             2             0
Arm/Group Title Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg) Total
Hide Arm/Group Description Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily Total of all reporting groups
Overall Number of Baseline Participants 25 50 25 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 50 participants 25 participants 100 participants
<=18 years
0
   0.0%
2
   4.0%
0
   0.0%
2
   2.0%
Between 18 and 65 years
25
 100.0%
48
  96.0%
25
 100.0%
98
  98.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 50 participants 25 participants 100 participants
39.1  (11.77) 38.6  (11.53) 39.6  (12.24) 39.0  (11.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 50 participants 25 participants 100 participants
Female
14
  56.0%
26
  52.0%
9
  36.0%
49
  49.0%
Male
11
  44.0%
24
  48.0%
16
  64.0%
51
  51.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 50 participants 25 participants 100 participants
25 50 25 100
1.Primary Outcome
Title Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)
Hide Description An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame Treatment period (up to 7 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Hide Arm/Group Description:
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Overall Number of Participants Analyzed 25 50 25
Measure Type: Number
Unit of Measure: subjects
17 42 20
2.Primary Outcome
Title Number of Subjects Who Withdrew From the Trial Due to an Adverse Event
Hide Description An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Hide Arm/Group Description:
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Overall Number of Participants Analyzed 25 50 25
Measure Type: Number
Unit of Measure: subjects
0 3 4
3.Secondary Outcome
Title Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion
Hide Description An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial including Pre-treatment, Run-In, Wash-Out, or Follow-Up Periods. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame 0-4 hours post start of the infusion
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Hide Arm/Group Description:
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Overall Number of Participants Analyzed 25 50 25
Measure Type: Number
Unit of Measure: subjects
5 24 16
Time Frame up to 7 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Hide Arm/Group Description Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
All-Cause Mortality
Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/50 (0.00%)      1/25 (4.00%)    
General disorders       
Chest pain * 1  0/25 (0.00%)  0 0/50 (0.00%)  0 1/25 (4.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide (200 mg) Lacosamide (300 mg) Lacosamide (400 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/25 (28.00%)      37/50 (74.00%)      20/25 (80.00%)    
Eye disorders       
Diplopia * 1  1/25 (4.00%)  1 3/50 (6.00%)  3 5/25 (20.00%)  6
Vision blurred * 1  0/25 (0.00%)  0 2/50 (4.00%)  2 3/25 (12.00%)  3
Gastrointestinal disorders       
Nausea * 1  0/25 (0.00%)  0 8/50 (16.00%)  8 6/25 (24.00%)  8
Dry mouth * 1  0/25 (0.00%)  0 3/50 (6.00%)  3 3/25 (12.00%)  3
Hypoaesthesia oral * 1  0/25 (0.00%)  0 3/50 (6.00%)  5 2/25 (8.00%)  2
Paraesthesia oral * 1  1/25 (4.00%)  1 2/50 (4.00%)  2 2/25 (8.00%)  2
Vomiting * 1  0/25 (0.00%)  0 2/50 (4.00%)  2 3/25 (12.00%)  3
Diarrhoea * 1  0/25 (0.00%)  0 4/50 (8.00%)  4 0/25 (0.00%)  0
General disorders       
Fatigue * 1  0/25 (0.00%)  0 9/50 (18.00%)  9 3/25 (12.00%)  3
Gait disturbance * 1  2/25 (8.00%)  2 1/50 (2.00%)  1 0/25 (0.00%)  0
Chest pain * 1  0/25 (0.00%)  0 0/50 (0.00%)  0 2/25 (8.00%)  2
Nervous system disorders       
Dizziness * 1  5/25 (20.00%)  6 23/50 (46.00%)  27 15/25 (60.00%)  19
Somnolence * 1  0/25 (0.00%)  0 17/50 (34.00%)  18 9/25 (36.00%)  9
Headache * 1  2/25 (8.00%)  2 2/50 (4.00%)  2 4/25 (16.00%)  4
Paraesthesia * 1  2/25 (8.00%)  2 3/50 (6.00%)  3 1/25 (4.00%)  4
Tremor * 1  0/25 (0.00%)  0 3/50 (6.00%)  3 1/25 (4.00%)  1
Coordination abnormal * 1  0/25 (0.00%)  0 3/50 (6.00%)  3 0/25 (0.00%)  0
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/25 (0.00%)  0 3/50 (6.00%)  3 1/25 (4.00%)  1
Hyperhidrosis * 1  0/25 (0.00%)  0 0/50 (0.00%)  0 2/25 (8.00%)  2
*
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.
UCB has > 60 days 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 results shall be published regardless of outcome.
Results Point of Contact
Name/Title: UCB Clinical Trial Call Center
Organization: UCB, Inc
Phone: +1 877 822 9493
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT00655551     History of Changes
Other Study ID Numbers: SP0925
2014-004378-40 ( EudraCT Number )
First Submitted: March 26, 2008
First Posted: April 10, 2008
Results First Submitted: September 23, 2010
Results First Posted: October 20, 2010
Last Update Posted: July 17, 2018