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

• 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: UCB Pharma
• 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

Participant Flow

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
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
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

Baseline Characteristics

Arm/Group Title		Lacosamide
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
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

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Study
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)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Lacosamide
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
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)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Lacosamide
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
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)

Outcome Measure Data

Analysis Population Description

Safety Set

Arm/Group Title	Lacosamide
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

Adverse Events

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
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	--/--
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
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)

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 of Results:

Baulac M, Coulbaut S, Doty P, McShea C, De Backer M, Bartolomei F, Vlaicu M. Adjunctive lacosamide for focal epilepsy: an open-label trial evaluating the impact of flexible titration and dosing on safety and seizure outcomes. Epileptic Disord. 2017 Jun 1;19(2):186-194. doi: 10.1684/epd.2017.0907.

• 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