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Trial record 1 of 1 for:    NCT01235403
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Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure (SELF)

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ClinicalTrials.gov Identifier: NCT01235403
Recruitment Status : Completed
First Posted : November 5, 2010
Results First Posted : January 24, 2013
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Partial Epilepsies
Intervention Drug: Lacosamide
Enrollment 100
Recruitment Details This is a 24-week study, which enrolled 100 patients at 44 sites in France.
Pre-assignment Details

The study comprises a 12-week Titration Phase and a 12-week Maintenance Phase; both phases together are regarded as the 24-week Treatment Period.

Participant Flow and Baseline Characteristics refer to the Safety Set (SS). The SS includes all subjects that received at least one dose of study medication.

Arm/Group Title Lacosamide
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Flexible dosing between 200 mg/day and 400 mg/day

Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Period Title: Overall Study
Started 100
Completed 74
Not Completed 26
Reason Not Completed
Adverse Event             14
Lost to Follow-up             2
Withdrawal by Subject             4
Lack of Efficacy             2
Other reasons for premature termination             4
Arm/Group Title Lacosamide
Hide Arm/Group Description

Flexible dosing between 200mg/day and 400mg/day

Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Overall Number of Baseline Participants 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
<=18 years
0
   0.0%
Between 18 and 65 years
88
  88.0%
>=65 years
12
  12.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants
44.5  (16.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants
Female
55
  55.0%
Male
45
  45.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
France Number Analyzed 100 participants
100
1.Primary Outcome
Title Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
Hide Description Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Time Frame During the study ( up to 24 - 28 weeks)
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Safety Set
Arm/Group Title Lacosamide
Hide Arm/Group Description:

Flexible dosing between 200 mg/day and 400 mg/day

Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: subjects
64
2.Primary Outcome
Title Number of Subjects Prematurely Discontinuing Due to a TEAE During the Study
Hide Description Number of subjects prematurely discontinuing due to a TEAE during the study. The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Time Frame During the study (up to 24 - 28 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Lacosamide
Hide Arm/Group Description:

Flexible dosing between 200 mg/day and 400 mg/day

Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: subjects
14
3.Secondary Outcome
Title Percentage of Subjects Retained on Vimpat Through the End of the 24-week Treatment Period
Hide Description

The number of subjects continuing on Vimpat up to and including Visit 4 (Week 24) divided by the number of patients who took at least 1 dose of Vimpat multiplied by 100.

The overall Treatment Period comprises of a 12-week Titration Phase and 12-week Maintenance Phase.

Time Frame End of Treatment Period (24-week)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set
Arm/Group Title Lacosamide
Hide Arm/Group Description:

Flexible dosing between 200 mg/day and 400 mg/day

Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

Overall Number of Participants Analyzed 100
Measure Type: Number
Unit of Measure: percentage of subjects
73
Time Frame During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description

Flexible dosing between 200mg/day and 400mg/day

Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks

All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   3/100 (3.00%)    
Eye disorders   
Diplopia * 1  1/100 (1.00%)  1
Gastrointestinal disorders   
Nausea * 1  1/100 (1.00%)  1
General disorders   
Gait disturbance * 1  1/100 (1.00%)  1
Nervous system disorders   
Coma * 1  1/100 (1.00%)  1
Dizziness * 1  1/100 (1.00%)  1
Partial seizures with secondary generalisation * 1  1/100 (1.00%)  1
Status epilepticus * 1  1/100 (1.00%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   49/100 (49.00%)    
General disorders   
Asthenia * 1  5/100 (5.00%)  5
Nervous system disorders   
Dizziness * 1  42/100 (42.00%)  46
Headache * 1  8/100 (8.00%)  9
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
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
ClinicalTrials.gov Identifier: NCT01235403    
Other Study ID Numbers: SP1007
2010-019268-35 ( EudraCT Number )
First Submitted: November 3, 2010
First Posted: November 5, 2010
Results First Submitted: December 18, 2012
Results First Posted: January 24, 2013
Last Update Posted: May 21, 2018