Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

• ClinicalTrials.gov Identifier: NCT01118962
• Recruitment Status: Completed
• First Posted: May 7, 2010
• Results First Posted: December 4, 2013
• Last Update Posted: July 17, 2018
• Sponsor: UCB BIOSCIENCES, Inc.
• Information provided by (Responsible Party): UCB Pharma ( UCB BIOSCIENCES, Inc. )

• 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: 39

Participant Flow

Recruitment Details	This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Pre-assignment Details

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
Period Title: Overall Study
Started	39
Completed	29
Not Completed	10
Reason Not Completed
Adverse Event	2
Lack of Efficacy	1
Protocol Violation	1
Withdrawal by Subject	4
Pregnancy	1
Non-compliance with Medicinal Product	1

Baseline Characteristics

Arm/Group Title		Lacosamide
Arm/Group Description		Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
Overall Number of Baseline Participants		39
Baseline Analysis Population Description		Baseline measurements consist of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants
	<=18 years	3 7.7%
	Between 18 and 65 years	36 92.3%
	>=65 years	0 0.0%
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	39 participants
		30.3 (10.7)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	39 participants
	Female	28 71.8%
	Male	11 28.2%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	39 participants
		39
Weight; Mean (Standard Deviation); Unit of measure: Kilograms
	Number Analyzed	39 participants
		77.66 (17.58)
Height; Mean (Standard Deviation); Unit of measure: Centimeters
	Number Analyzed	39 participants
		167.88 (8.25)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
Description	[Not Specified]
Time Frame	From Visit 1 to the end of study (Approximately 61 weeks)

Outcome Measure Data

Analysis Population Description

Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.

The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).

Arm/Group Title	Lacosamide
Arm/Group Description:	Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
Overall Number of Participants Analyzed	39
Measure Type: Number; Unit of Measure: participants
	37

2. Primary Outcome

Title	Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
Description	[Not Specified]
Time Frame	From Visit 1 to the end of study (Approximately 61 weeks)

Outcome Measure Data

Analysis Population Description

Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.

The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).

Arm/Group Title	Lacosamide
Arm/Group Description:	Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
Overall Number of Participants Analyzed	39
Measure Type: Number; Unit of Measure: participants
	2

Adverse Events

Time Frame	Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.
All-Cause Mortality
	Lacosamide
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	3/39 (7.69%)
Infections and infestations
PNEUMONIA * 1	1/39 (2.56%)	1
Nervous system disorders
CONVULSION * 1	1/39 (2.56%)	1
MIGRAINE * 1	1/39 (2.56%)	1
Psychiatric disorders
ABNORMAL BEHAVIOUR * 1	1/39 (2.56%)	1
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Lacosamide
	Affected / at Risk (%)	# Events
Total	35/39 (89.74%)
Cardiac disorders
PALPITATIONS * 1	2/39 (5.13%)	2
Eye disorders
DIPLOPIA * 1	3/39 (7.69%)	4
Gastrointestinal disorders
NAUSEA * 1	5/39 (12.82%)	5
DIARRHOEA * 1	2/39 (5.13%)	2
General disorders
FATIGUE * 1	3/39 (7.69%)	4
GAIT DISTURBANCE * 1	2/39 (5.13%)	2
Immune system disorders
SEASONAL ALLERGY * 1	3/39 (7.69%)	3
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION * 1	10/39 (25.64%)	13
SINUSITIS * 1	3/39 (7.69%)	3
GASTROENTERITIS VIRAL * 1	2/39 (5.13%)	3
INFLUENZA * 1	2/39 (5.13%)	2
TOOTH ABSCESS * 1	2/39 (5.13%)	2
Injury, poisoning and procedural complications
FALL * 1	4/39 (10.26%)	4
JOINT SPRAIN * 1	4/39 (10.26%)	5
CONTUSION * 1	3/39 (7.69%)	3
EXCORIATION * 1	2/39 (5.13%)	2
MUSCLE STRAIN * 1	2/39 (5.13%)	2
SKIN LACERATION * 1	2/39 (5.13%)	2
Investigations
WEIGHT INCREASED * 1	4/39 (10.26%)	4
ALANINE AMINOTRANSFERASE INCREASED * 1	2/39 (5.13%)	2
ARTERIAL BRUIT * 1	2/39 (5.13%)	2
ASPARTATE AMINOTRANSFERASE INCREASED * 1	2/39 (5.13%)	2
GAMMA-GLUTAMYLTRANSFERASE INCREASED * 1	2/39 (5.13%)	2
Metabolism and nutrition disorders
INCREASED APPETITE * 1	2/39 (5.13%)	2
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN * 1	3/39 (7.69%)	3
ARTHRALGIA * 1	2/39 (5.13%)	4
Nervous system disorders
DIZZINESS * 1	10/39 (25.64%)	12
HEADACHE * 1	7/39 (17.95%)	12
TREMOR * 1	6/39 (15.38%)	6
POSTICTAL STATE * 1	2/39 (5.13%)	9
Psychiatric disorders
ANXIETY * 1	4/39 (10.26%)	5
CONFUSIONAL STATE * 1	4/39 (10.26%)	4
DEPRESSION * 1	2/39 (5.13%)	2
Respiratory, thoracic and mediastinal disorders
DYSPNOEA * 1	4/39 (10.26%)	4
RESPIRATORY DISORDER * 1	2/39 (5.13%)	2
Skin and subcutaneous tissue disorders
ALOPECIA * 1	2/39 (5.13%)	2
* Indicates events were collected by non-systematic assessment; 1 Term from vocabulary, MedDRA (9.1)

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.

UCB has > 60 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 the results shall be published regardless of outcome.

Results Point of Contact

• Name/Title: UCB (Study Director)
• Organization: UCB Clinical Trial Call Center
• Phone: +1 887 822 9493

Publications of Results:

Wechsler RT, Yates SL, Messenheimer J, Leroy R, Beller C, Doty P. Lacosamide for uncontrolled primary generalized tonic-clonic seizures: An open-label pilot study with 59-week extension. Epilepsy Res. 2017 Feb;130:13-20. doi: 10.1016/j.eplepsyres.2016.12.015. Epub 2016 Dec 29.

• Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
• ClinicalTrials.gov Identifier: NCT01118962
• Other Study ID Numbers: SP0962; 2014-004375-23 ( EudraCT Number )
• First Submitted: May 5, 2010
• First Posted: May 7, 2010
• Results First Submitted: October 7, 2013
• Results First Posted: December 4, 2013
• Last Update Posted: July 17, 2018