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

• Sponsor: UCB BIOSCIENCES, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01118962
• Collaborator: (none)
• Enrollment: 39
• Locations: 19
• Arm: 1
• Duration (Months): 26
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Lacosamide	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Long-Term Oral Lacosamide for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Oct 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Lacosamide 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.

Drug: Lacosamide; 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). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.; Other Names: Vimpat®

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks) [From Visit 1 to the end of study (Approximately 61 weeks)]

2. 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) [From Visit 1 to the end of study (Approximately 61 weeks)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject completed the SP0961 (NCT01118949) study

• Subject is expected to benefit from participation in an open-label extension study with Lacosamide, in the opinion of the investigator

Exclusion Criteria:

• Subject meets the withdrawal criteria for SP0961 (NCT01118949) or is experiencing an ongoing Serious Adverse Event (SAE)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	603	Phoenix	Arizona	United States
2	602	Little Rock	Arkansas	United States
3	628	Aurora	Colorado	United States
4	613	Atlanta	Georgia	United States
5	617	Boise	Idaho	United States
6	614	Fort Wayne	Indiana	United States
7	605	Lexington	Kentucky	United States
8	616	Louisville	Kentucky	United States
9	619	Scarborough	Maine	United States
10	609	Bethesda	Maryland	United States
11	615	Chesterfield	Missouri	United States
12	607	New York	New York	United States
13	620	Columbus	Ohio	United States
14	608	Charleston	South Carolina	United States
15	601	Nashville	Tennessee	United States
16	612	Dallas	Texas	United States
17	610	Norfolk	Virginia	United States
18	623	Renton	Washington	United States
19	624	Madison	Wisconsin	United States

Sponsors and Collaborators

• UCB BIOSCIENCES, Inc.

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Product Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB BIOSCIENCES, Inc.
• ClinicalTrials.gov Identifier: NCT01118962
• Other Study ID Numbers: SP0962; 2014-004375-23
• First Posted: May 7, 2010
• Last Update Posted: Jul 17, 2018
• Last Verified: Mar 1, 2018

• Keywords provided by UCB BIOSCIENCES, Inc.: Primary Generalized Tonic-Clonic (PGTC) Seizures; Absence Seizures; Myoclonic Seizures; Idiopathic Generalized Epilepsy (IGE)
• Additional relevant MeSH terms: Epilepsy; Seizures; Lacosamide

Study Results

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).

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

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 Participants	39
Age (Count of Participants)
<=18 years	3 7.7%
Between 18 and 65 years	36 92.3%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.3 (10.7)
Sex: Female, Male (Count of Participants)
Female	28 71.8%
Male	11 28.2%
Region of Enrollment (participants) [Number]
United States	39 100%
Weight (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	77.66 (17.58)
Height (Centimeters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Centimeters]	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)
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.
Measure Participants	39
Number [participants]	37 94.9%

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)
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.
Measure Participants	39
Number [participants]	2 5.1%

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).
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	3/39 (7.7%)
Infections and infestations
PNEUMONIA	1/39 (2.6%)	1
Nervous system disorders
CONVULSION	1/39 (2.6%)	1
MIGRAINE	1/39 (2.6%)	1
Psychiatric disorders
ABNORMAL BEHAVIOUR	1/39 (2.6%)	1
Other (Not Including Serious) Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	35/39 (89.7%)
Cardiac disorders
PALPITATIONS	2/39 (5.1%)	2
Eye disorders
DIPLOPIA	3/39 (7.7%)	4
Gastrointestinal disorders
NAUSEA	5/39 (12.8%)	5
DIARRHOEA	2/39 (5.1%)	2
General disorders
FATIGUE	3/39 (7.7%)	4
GAIT DISTURBANCE	2/39 (5.1%)	2
Immune system disorders
SEASONAL ALLERGY	3/39 (7.7%)	3
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION	10/39 (25.6%)	13
SINUSITIS	3/39 (7.7%)	3
GASTROENTERITIS VIRAL	2/39 (5.1%)	3
INFLUENZA	2/39 (5.1%)	2
TOOTH ABSCESS	2/39 (5.1%)	2
Injury, poisoning and procedural complications
FALL	4/39 (10.3%)	4
JOINT SPRAIN	4/39 (10.3%)	5
CONTUSION	3/39 (7.7%)	3
EXCORIATION	2/39 (5.1%)	2
MUSCLE STRAIN	2/39 (5.1%)	2
SKIN LACERATION	2/39 (5.1%)	2
Investigations
WEIGHT INCREASED	4/39 (10.3%)	4
ALANINE AMINOTRANSFERASE INCREASED	2/39 (5.1%)	2
ARTERIAL BRUIT	2/39 (5.1%)	2
ASPARTATE AMINOTRANSFERASE INCREASED	2/39 (5.1%)	2
GAMMA-GLUTAMYLTRANSFERASE INCREASED	2/39 (5.1%)	2
Metabolism and nutrition disorders
INCREASED APPETITE	2/39 (5.1%)	2
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN	3/39 (7.7%)	3
ARTHRALGIA	2/39 (5.1%)	4
Nervous system disorders
DIZZINESS	10/39 (25.6%)	12
HEADACHE	7/39 (17.9%)	12
TREMOR	6/39 (15.4%)	6
POSTICTAL STATE	2/39 (5.1%)	9
Psychiatric disorders
ANXIETY	4/39 (10.3%)	5
CONFUSIONAL STATE	4/39 (10.3%)	4
DEPRESSION	2/39 (5.1%)	2
Respiratory, thoracic and mediastinal disorders
DYSPNOEA	4/39 (10.3%)	4
RESPIRATORY DISORDER	2/39 (5.1%)	2
Skin and subcutaneous tissue disorders
ALOPECIA	2/39 (5.1%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.