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Trial to Assess Lacosamide as the First add-on Anti-epileptic Drug Treatment in Patients With Partial-onset Seizures

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ClinicalTrials.gov Identifier: NCT00955357
Recruitment Status : Completed
First Posted : August 10, 2009
Results First Posted : May 1, 2014
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Epilepsies
Intervention Drug: Lacosamide
Enrollment 461
Recruitment Details An estimated 656 subjects were to be enrolled in the study at approximately 130 sites in the US, Europe, and the rest of the world.
Pre-assignment Details Overall 461 subjects were enrolled. The Participant Flow refers to the Safety Set (SS) which was defined as all enrolled subjects who took at least 1 dose of Lacosamide. Reasons for discontinuation were only calculated for the SS. 456 subjects were included in the Safety Set.
Arm/Group Title First Add-on Later Add-on
Hide Arm/Group Description

Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Period Title: Titration Phase
Started 96 360
Completed 80 294
Not Completed 16 66
Reason Not Completed
Adverse Event             9             46
Lack of Efficacy             0             2
Protocol Violation             3             7
Lost to Follow-up             1             3
Withdrawal by Subject             3             5
Prohibited Antiepileptic Drug change             0             1
Study medication not tolerated             0             1
Non compliance to study procedures             0             1
Period Title: Maintenance Phase
Started 80 294
Completed 68 249
Not Completed 12 45
Reason Not Completed
Adverse Event             3             23
Lack of Efficacy             0             4
Protocol Violation             2             6
Lost to Follow-up             2             7
Withdrawal by Subject             4             4
Patient moving out of area             0             1
Non compliance to study procedures             1             0
Arm/Group Title First Add-on Later-Add-on Total
Hide Arm/Group Description

Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

 Total of all reporting groups
Overall Number of Baseline Participants 96 360 456
Hide Baseline Analysis Population Description
The Baseline Analysis Population refers to the Safety Set (SS) which includes all enrolled subjects who took at least one dose of study medication. 5 subjects at one site were excluded from the Safety Set due to significant study conduct deficiencies.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 96 participants 360 participants 456 participants
37.5
(18.0 to 82.0)
38.0
(16.0 to 74.0)
38.0
(16.0 to 82.0)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 360 participants 456 participants
<=18 years
4
   4.2%
7
   1.9%
11
   2.4%
Between 18 and 65 years
82
  85.4%
349
  96.9%
431
  94.5%
>=65 years
10
  10.4%
4
   1.1%
14
   3.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 360 participants 456 participants
Female
53
  55.2%
180
  50.0%
233
  51.1%
Male
43
  44.8%
180
  50.0%
223
  48.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 360 participants 456 participants
American Indian or Alaska Native
11
  11.5%
6
   1.7%
17
   3.7%
Asian
0
   0.0%
12
   3.3%
12
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.0%
19
   5.3%
20
   4.4%
White
79
  82.3%
278
  77.2%
357
  78.3%
More than one race
5
   5.2%
45
  12.5%
50
  11.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 96 participants 360 participants 456 participants
Hispanic or Latino
24
  25.0%
99
  27.5%
123
  27.0%
Not Hispanic or Latino
72
  75.0%
261
  72.5%
333
  73.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Median (Full Range)
Unit of measure:  Kilogram
Number Analyzed 96 participants 360 participants 456 participants
71.8
(42.0 to 132.9)
73.0
(41.9 to 147.4)
73.0
(41.9 to 147.4)
Height  
Median (Full Range)
Unit of measure:  Centimeter
Number Analyzed 96 participants 360 participants 456 participants
166.5
(149.0 to 186.0)
167.6
(140.0 to 197.0)
167.6
(140.0 to 197.0)
BMI  
Median (Full Range)
Unit of measure:  Kilogram per m^2
Number Analyzed 96 participants 360 participants 456 participants
25.3
(14.5 to 42.5)
25.5
(17.3 to 53.9)
25.4
(14.5 to 53.9)
1.Primary Outcome
Title The Proportion of Subjects Who Achieved "Seizure-free Status" During the First 12 Weeks of the Maintenance Phase
Hide Description

A subject will be considered seizure-free if the subject completes the first 12 weeks of the Maintenance Phase, reports zero seizures, and has no seizure data missing for any day during the period of time.

This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.
Time Frame From Week 7 (end of Week 6) to end of Week 18
Hide Outcome Measure Data
Hide Analysis Population Description
The Analysis Population refers to the Completer Set (CS) which includes all subjects who were enrolled, received at least one dose of Lacosamide and completed the first 12 weeks of the Maintenance Phase.
Arm/Group Title First Add-on Later Add-on
Hide Arm/Group Description:

Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
Overall Number of Participants Analyzed 72 261
Measure Type: Number
Unit of Measure: percentage of subjects
37.5 14.9
Time Frame Treatment Emergent Adverse Events were collected from Screening (Week -1) until the end of the study ( up to Week 33).
Adverse Event Reporting Description Treatment Emergent Adverse Events started on/after the date of first dose and within 30 days of the date of last dose.
 
Arm/Group Title First Add-on Later Add-on
Hide Arm/Group Description

Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week

Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.

Lacosamide: oral tablet

Subjects Titration Phase (6 Weeks):

Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid

Maintenance Phase (24 Weeks):

200 mg tablet bid OR 150 mg tablet bid

Taper Phase (1 - 3 Weeks):

50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week
All-Cause Mortality
First Add-on Later Add-on
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
First Add-on Later Add-on
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/96 (8.33%)      19/360 (5.28%)    
Blood and lymphatic system disorders     
Agranulocytosis * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Cardiac disorders     
Angina pectoris * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Eye disorders     
Diplopia * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
General disorders     
Pyrexia * 1  0/96 (0.00%)  0 2/360 (0.56%)  2
Chest discomfort * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Infections and infestations     
Pneumonia * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Tooth abscess * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Urinary tract infection * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Injury, poisoning and procedural complications     
Arthropod bite * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Femoral neck fracture * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Hip fracture * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Humerus fracture * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Joint dislocation * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Subdural haematoma * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Investigations     
Electrocardiogram ST segment elevation * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Metabolism and nutrition disorders     
Hypochloraemia * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Hyponatraemia * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Nervous system disorders     
Convulsion * 1  2/96 (2.08%)  2 2/360 (0.56%)  2
Dizziness * 1  0/96 (0.00%)  0 2/360 (0.56%)  2
Complex partial seizures * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Coordination abnormal * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Dysarthria * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Dyskinesia * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Epilepsy * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Grand mal convulsion * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Headache * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Lacunar infarction * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Partial seizures with secondary generalisation * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Psychiatric disorders     
Panic attack * 1  0/96 (0.00%)  0 1/360 (0.28%)  1
Suicide attempt * 1  1/96 (1.04%)  1 0/360 (0.00%)  0
Surgical and medical procedures     
Abortion induced * 1  1/96 (1.04%)  1 1/360 (0.28%)  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%
First Add-on Later Add-on
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   53/96 (55.21%)      212/360 (58.89%)    
Ear and labyrinth disorders     
Vertigo * 1  9/96 (9.38%)  11 22/360 (6.11%)  22
Eye disorders     
Vision blurred * 1  2/96 (2.08%)  3 24/360 (6.67%)  28
Diplopia * 1  7/96 (7.29%)  7 17/360 (4.72%)  17
Gastrointestinal disorders     
Nausea * 1  8/96 (8.33%)  8 24/360 (6.67%)  27
Infections and infestations     
Influenza * 1  5/96 (5.21%)  5 4/360 (1.11%)  4
Nervous system disorders     
Dizziness * 1  30/96 (31.25%)  37 119/360 (33.06%)  159
Somnolence * 1  6/96 (6.25%)  8 54/360 (15.00%)  65
Headache * 1  13/96 (13.54%)  19 41/360 (11.39%)  57
Tremor * 1  3/96 (3.13%)  3 22/360 (6.11%)  23
Psychiatric disorders     
Anxiety * 1  6/96 (6.25%)  6 4/360 (1.11%)  4
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.1
This study was intended to assess the efficacy outcomes in the First Add-On Group and the Later Add-On Group individually relative to historical data. Comparisons between the 2 groups should not be attempted and conclusions should not be drawn.
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
ClinicalTrials.gov Identifier: NCT00955357    
Other Study ID Numbers: SP0954
2009-011181-28 ( EudraCT Number )
First Submitted: August 6, 2009
First Posted: August 10, 2009
Results First Submitted: March 28, 2014
Results First Posted: May 1, 2014
Last Update Posted: July 17, 2018