A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994

• ClinicalTrials.gov Identifier: NCT02582866
• Recruitment Status: Completed
• First Posted: October 21, 2015
• Results First Posted: January 22, 2021
• Last Update Posted: August 17, 2021
• Sponsor: UCB Biopharma S.P.R.L.
• Collaborator: Parexel
• Information provided by (Responsible Party): UCB Pharma ( UCB Biopharma S.P.R.L. )

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Epilepsy
• Intervention: Drug: Lacosamide
• Enrollment: 106

Participant Flow

Recruitment Details	The study started to enroll study participants in January 2016 and concluded in January 2020.
Pre-assignment Details	Participant Flow refers to the Safety Set.

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.
Period Title: Overall Study
Started	106
Completed	84
Not Completed	22
Reason Not Completed
Death	1
Lack of Efficacy	2
Lost to Follow-up	2
Withdrawal by Subject	7
Investigator decision	5
Participant wants to get pregnant	1
Pregnancy	2
Sponsor decision	1
Withdrawal due to personal reasons	1

Baseline Characteristics

Arm/Group Title		Lacosamide
Arm/Group Description		Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks.
Overall Number of Baseline Participants		106
Baseline Analysis Population Description		Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of study medication in SP1042.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants
	<=18 years	2 1.9%
	Between 18 and 65 years	90 84.9%
	>=65 years	14 13.2%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	106 participants
		43.5 (17.1)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants
	Female	48 45.3%
	Male	58 54.7%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	106 participants
	Asian	19 17.9%
	White	86 81.1%
	Other/Mixed	1 0.9%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Experiencing Any Adverse Events (AEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Description	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time Frame	From Visit 1 (Week 0) to Final Visit (up to Week 158)

Outcome Measure Data

Analysis Population Description

The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.

Arm/Group Title	Lacosamide (SS)
Arm/Group Description:	Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed	106
Measure Type: Number; Unit of Measure: percentage of participants
	59.4

2. Primary Outcome

Title	Percentage of Participants That Withdrew Due to Adverse Events (AEs)
Description	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE could, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study medication.
Time Frame	From Visit 1 (Week 0) to Final Visit (up to Week 158)

Outcome Measure Data

Analysis Population Description

The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.

Arm/Group Title	Lacosamide (SS)
Arm/Group Description:	Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed	106
Measure Type: Number; Unit of Measure: percentage of participants
	0.9

3. Primary Outcome

Title	Percentage of Participants Experiencing Any Serious Adverse Events (SAEs) Reported Spontaneously by the Subject and/or Caregiver or Observed by Investigator
Description	A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: Results in death; Is life-threatening; Requires in patient hospitalization or prolongation of existing hospitalization; Is a congenital anomaly or birth defect; Is an infection that requires treatment parenteral antibiotics; Other important medical events which based on medical or scientific judgement may jeopardize the study participants, or may require medical or surgical intervention to prevent any of the above.
Time Frame	From Visit 1 (Week 0) to Final Visit (up to Week 158)

Outcome Measure Data

Analysis Population Description

The SS consisted of all study participants in the ES who received at least 1 dose of study medication in SP1042.

Arm/Group Title	Lacosamide (SS)
Arm/Group Description:	Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS).
Overall Number of Participants Analyzed	106
Measure Type: Number; Unit of Measure: percentage of participants
	14.2

Adverse Events

Time Frame	Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Lacosamide (SS)
Arm/Group Description	Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS).
All-Cause Mortality
	Lacosamide (SS)
	Affected / at Risk (%)
Total	1/106 (0.94%)
Serious Adverse Events
	Lacosamide (SS)
	Affected / at Risk (%)	# Events
Total	15/106 (14.15%)
Cardiac disorders
Atrial Flutter * 1	1/106 (0.94%)	1
Cardiac Failure * 1	1/106 (0.94%)	1
Myocardial Infarction * 1	1/106 (0.94%)	1
Ventricular Tachycardia * 1	1/106 (0.94%)	1
Gastrointestinal disorders
Diarrhoea * 1	1/106 (0.94%)	1
Gastrooesophageal Reflux Disease * 1	1/106 (0.94%)	1
Umbilical Hernia * 1	1/106 (0.94%)	1
General disorders
Device Dislocation * 1	1/106 (0.94%)	1
Sudden Unexplained Death In Epilepsy * 1	1/106 (0.94%)	1
Injury, poisoning and procedural complications
Forearm Fracture * 1	1/106 (0.94%)	1
Post Gastric Surgery Syndrome * 1	1/106 (0.94%)	1
Tibia Fracture * 1	1/106 (0.94%)	1
Investigations
Arteriogram Coronary * 1	1/106 (0.94%)	1
Metabolism and nutrition disorders
Hypoglycaemia * 1	1/106 (0.94%)	1
Musculoskeletal and connective tissue disorders
Osteoarthritis * 1	2/106 (1.89%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer * 1	1/106 (0.94%)	1
Nervous system disorders
Epilepsy * 1	2/106 (1.89%)	2
Ischaemic Stroke * 1	1/106 (0.94%)	1
Peripheral Sensorimotor Neuropathy * 1	1/106 (0.94%)	1
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome * 1	1/106 (0.94%)	1
Dyspnoea * 1	1/106 (0.94%)	1
Surgical and medical procedures
Knee Arthroplasty * 1	1/106 (0.94%)	1
1 Term from vocabulary, MedDRA16.1; * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lacosamide (SS)
	Affected / at Risk (%)	# Events
Total	19/106 (17.92%)
Infections and infestations
Nasopharyngitis * 1	8/106 (7.55%)	17
Nervous system disorders
Headache * 1	11/106 (10.38%)	11
1 Term from vocabulary, MedDRA16.1; * Indicates events were collected by non-systematic assessment

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
• Organization: Cares
• Phone: +1844 599 ext 2273
• EMail: UCBCares@ucb.com

Publications of Results:

Ben-Menachem E, Dominguez J, Szász J, Beller C, Howerton C, Jensen L, McClung C, Roebling R, Steiniger-Brach B. Long-term safety and tolerability of lacosamide monotherapy in patients with epilepsy: Results from a multicenter, open-label trial. Epilepsia Open. 2021 Sep;6(3):618-623. doi: 10.1002/epi4.12522. Epub 2021 Aug 2.

• Responsible Party: UCB Pharma ( UCB Biopharma S.P.R.L. )
• ClinicalTrials.gov Identifier: NCT02582866
• Other Study ID Numbers: SP1042; 2015-001549-96 ( EudraCT Number )
• First Submitted: October 20, 2015
• First Posted: October 21, 2015
• Results First Submitted: January 4, 2021
• Results First Posted: January 22, 2021
• Last Update Posted: August 17, 2021