Trial to Assess Long-term Lacosamide (LCM) Monotherapy Use and Safety of LCM Monotherapy and Adjunctive Therapy for Partial-onset Seizures

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00530855
• Collaborator: (none)
• Enrollment: 322
• Locations: 108
• Arm: 1
• Duration (Months): 82
• Patients Per Site: 3
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This open-label extension trial will assess the long-term use of Lacosamide monotherapy and safety of Lacosamide monotherapy and adjunctive therapy in subjects with partial-onset seizures who were previously enrolled in the conversion to monotherapy trial (SP902).

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Lacosamide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 322 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-label Extension Trial to Assess the Long-term Use of Lacosamide Monotherapy and Safety of Lacosamide Monotherapy and Adjunctive Therapy in Subjects With Partial-onset Seizures
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lacosamide Lacosamide tablets for dosing 100 -800 mg/day	Drug: Lacosamide; 50 mg and 100 mg Lacosamide tablets taken for 50 -400 mg twice daily dosing for up to 2 years; Other Names: Vimpat

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study [From Visit 1 to End of Study (approximately 2 years)]

   Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.

2. Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study [From Visit 1 to End of Study (approximately 2 years)]

   Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.

Secondary Outcome Measures

1. Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study [From Visit 1 to End of Study (approximately 2 years)]

   A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).

2. Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study [From Visit 1 to End of Study (approximately 2 years)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has entered the Maintenance Phase of the double-blind trial, SP902, (ie, has taken at least 1 dose of SP902 Maintenance Phase trial medication) and either completed SP902 or met an exit criterion in SP902; subject is allowed up to 2 concomitant Antiepileptic Drugs (AEDs)

Exclusion Criteria:

• Subject meets the withdrawal criteria (excluding exit criteria) for the SP902 trial, or is experiencing an ongoing Serious Adverse Event (SAE)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	048	Alabaster	Alabama	United States
2	010	Birmingham	Alabama	United States
3	042	Northport	Alabama	United States
4	009	Phoenix	Arizona	United States
5	014	Phoenix	Arizona	United States
6	151	Phoenix	Arizona	United States
7	103	Tucson	Arizona	United States
8	102	Jonesboro	Arkansas	United States
9	007	Little Rock	Arkansas	United States
10	086	Little Rock	Arkansas	United States
11	120	La Habra	California	United States
12	059	Los Angeles	California	United States
13	021	Santa Monica	California	United States
14	107	Torrance	California	United States
15	060	Aurora	Colorado	United States
16	025	Fairfield	Connecticut	United States
17	094	Doral	Florida	United States
18	108	Gainesville	Florida	United States
19	123	Miami	Florida	United States
20	132	Miami	Florida	United States
21	077	Orlando	Florida	United States
22	049	Panama City	Florida	United States
23	129	Port Charlotte	Florida	United States
24	050	Sarasota	Florida	United States
25	004	Tallahassee	Florida	United States
26	079	Atlanta	Georgia	United States
27	058	Boise	Idaho	United States
28	131	Hines	Illinois	United States
29	146	Peoria	Illinois	United States
30	011	Springfield	Illinois	United States
31	078	Indianapolis	Indiana	United States
32	073	Ames	Iowa	United States
33	124	Manhattan	Kansas	United States
34	023	Wichita	Kansas	United States
35	160	Wichita	Kansas	United States
36	164	Lexington	Kentucky	United States
37	062	Louisville	Kentucky	United States
38	029	Scarborough	Maine	United States
39	020	Baltimore	Maryland	United States
40	034	Baltimore	Maryland	United States
41	065	Pikesville	Maryland	United States
42	137	Waldorf	Maryland	United States
43	041	Detroit	Michigan	United States
44	030	Golden Valley	Minnesota	United States
45	071	Hattiesburg	Mississippi	United States
46	031	Chesterfield	Missouri	United States
47	066	Saint Louis	Missouri	United States
48	017	Lebanon	New Hampshire	United States
49	067	Voorhees	New Jersey	United States
50	036	Albany	New York	United States
51	083	Buffalo	New York	United States
52	069	Cedarhurst	New York	United States
53	027	New York	New York	United States
54	122	New York	New York	United States
55	003	Asheville	North Carolina	United States
56	063	Durham	North Carolina	United States
57	117	Wilmington	North Carolina	United States
58	015	Cleveland	Ohio	United States
59	061	Columbus	Ohio	United States
60	002	Toledo	Ohio	United States
61	147	Oklahoma City	Oklahoma	United States
62	100	Greensburg	Pennsylvania	United States
63	032	Philadelphia	Pennsylvania	United States
64	024	Beaufort	South Carolina	United States
65	114	Chattanooga	Tennessee	United States
66	001	Nashville	Tennessee	United States
67	138	Austin	Texas	United States
68	022	Dallas	Texas	United States
69	046	El Paso	Texas	United States
70	051	Houston	Texas	United States
71	053	Houston	Texas	United States
72	098	San Antonio	Texas	United States
73	136	Layton	Utah	United States
74	161	Alexandria	Virginia	United States
75	016	Charlottesville	Virginia	United States
76	074	Renton	Washington	United States
77	080	Madison	Wisconsin	United States
78	421	Capmerdown	New South Wales	Australia
79	425	Chatswood	New South Wales	Australia
80	423	Herston	Queensland	Australia
81	420	Adelaide	South Australia	Australia
82	427	Parkville	Victoria	Australia
83	140	Halifax	Nova Scotia	Canada
84	116	Hamilton	Ontario	Canada
85	093	London	Ontario	Canada
86	091	Greenfield Park	Quebec	Canada
87	110	Montreal	Quebec	Canada
88	113	Montreal	Quebec	Canada
89	127	Calgary		Canada
90	223	Aarhus		Denmark
91	461	Mainz		Germany
92	443	Ferrara		Italy
93	445	Reggio Calabria		Italy
94	447	Torrette Di Ancona		Italy
95	284	Czestochowa		Poland
96	286	Gdansk		Poland
97	282	Gdynia		Poland
98	280	Krakow		Poland
99	290	Lublin		Poland
100	289	Szczecin		Poland
101	281	Warszawa		Poland
102	287	Warszawa		Poland
103	324	Santa Cruz de Tenerife		Spain
104	360	Blackpool		United Kingdom
105	367	Cornwall		United Kingdom
106	364	London		United Kingdom
107	369	London		United Kingdom
108	363	Middlesborough		United Kingdom

Sponsors and Collaborators

• UCB Pharma

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 Pharma
• ClinicalTrials.gov Identifier: NCT00530855
• Other Study ID Numbers: SP0904; 2007-005440-25
• First Posted: Sep 18, 2007
• Last Update Posted: Jul 18, 2018
• Last Verified: Jul 1, 2017

• Keywords provided by UCB Pharma: Epilepsy; Partial-onset Seizures; Lacosamide; Monotherapy; Vimpat
• Additional relevant MeSH terms: Epilepsy; Seizures; Lacosamide

Study Results

Participant Flow

Recruitment Details	This Multicenter, Open-Label Study started to enroll Subjects in February 2008.
Pre-assignment Detail	Participant Flow refers to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
Period Title: Overall Study
STARTED	322
COMPLETED	210
NOT COMPLETED	112

Baseline Characteristics

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
Overall Participants	322
Age (Count of Participants)
<=18 years	8 2.5%
Between 18 and 65 years	301 93.5%
>=65 years	13 4%
Age (years) [Mean (Standard Deviation) ]
mean (standard deviation)	40.7 (13.3)
Sex: Female, Male (Count of Participants)
Female	161 50%
Male	161 50%
Race/Ethnicity, Customized (Number) [Number]
White	258 80.1%
Black or African American	46 14.3%
Asian	1 0.3%
Other	17 5.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects on Lacosamide (LCM) Monotherapy at Any Time Between Visit 1 and End of Study
Description	Percentage of Subjects on Lacosamide (LCM) Monotherapy at any time between Visit 1 and End of Study.
Time Frame	From Visit 1 to End of Study (approximately 2 years)

Outcome Measure Data

Analysis Population Description

All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
Measure Participants	322
Number [Participants]	292 90.7%

2. Primary Outcome

Title	Duration of Lacosamide (LCM) Monotherapy Treatment From Visit 1 to End of Study
Description	Duration of total Lacosamide Monotherapy From Visit 1 to End of Study.
Time Frame	From Visit 1 to End of Study (approximately 2 years)

Outcome Measure Data

Analysis Population Description

All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
Measure Participants	322
Mean (Standard Deviation) [days]	479.1 (271.9)

3. Secondary Outcome

Title	Occurrence of At Least One Treatment-Emergent Adverse Event (TEAE) From Visit 1 to End of Study
Description	A TEAE is defined as any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any phase of a clinical trial including Pretreatment, Run-In, Wash-Out, or Follow-Up Phases. An TEAE is defined as being independent of assumption of any causality (eg, to trial or concomitant medication, primary or concomitant disease, or trial design).
Time Frame	From Visit 1 to End of Study (approximately 2 years)

Outcome Measure Data

Analysis Population Description

All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
Measure Participants	322
Number [Participants]	296 91.9%

4. Secondary Outcome

Title	Occurrence of Treatment-Emergent Adverse Events (TEAE) Leading to Subject Withdrawal From Visit 1 to End of Study
Time Frame	From Visit 1 to End of Study (approximately 2 years)

Outcome Measure Data

Analysis Population Description

All 322 Subjects from the Safety Set are included in the Analysis of this Outcome Measure. Safety Set is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.

Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
Measure Participants	322
Number [Participants]	22 6.8%

Adverse Events

Time Frame	Adverse Events were collected from Study Start (Visit 1) until the End of Study (up to 2 years).
Adverse Event Reporting Description	Adverse Events refer to the Safety Set, which is defined as all subjects who met the inclusion/exclusion criteria, signed an informed consent form, and took at least 1 dose of Trial medication.
Arm/Group Title	Lacosamide
Arm/Group Description	Lacosamide tablets for dosing 100 -800 mg/day
All Cause Mortality
	Lacosamide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	56/322 (17.4%)
Blood and lymphatic system disorders
Anaemia	1/322 (0.3%)	1
Cardiac disorders
Congestive cardiomyopathy	1/322 (0.3%)	1
Angina unstable	1/322 (0.3%)	1
Bradycardia	1/322 (0.3%)	1
Cardiac arrest	1/322 (0.3%)	1
Cardiac tamponade	1/322 (0.3%)	1
Eye disorders
Vision blurred	1/322 (0.3%)	1
Gastrointestinal disorders
Intestinal obstruction	1/322 (0.3%)	1
Melaena	1/322 (0.3%)	1
General disorders
Pyrexia	1/322 (0.3%)	2
Sudden unexplained death in epilepsy	1/322 (0.3%)	1
Chest pain	1/322 (0.3%)	1
Pain	1/322 (0.3%)	1
Hepatobiliary disorders
Cholecystitis	1/322 (0.3%)	1
Infections and infestations
Appendicitis	1/322 (0.3%)	1
Bacteraemia	1/322 (0.3%)	1
Gastroenteritis	1/322 (0.3%)	1
Pneumonia	1/322 (0.3%)	1
Sepsis	1/322 (0.3%)	1
Cellulitis	1/322 (0.3%)	1
Tubo-ovarian abscess	1/322 (0.3%)	1
Urinary tract infection	1/322 (0.3%)	1
Injury, poisoning and procedural complications
Rib fracture	2/322 (0.6%)	2
Cervical vertebral fracture	1/322 (0.3%)	1
Concussion	1/322 (0.3%)	1
Contusion	1/322 (0.3%)	1
Foot fracture	1/322 (0.3%)	1
Laceration	1/322 (0.3%)	1
Pulmonary contusion	1/322 (0.3%)	1
Road traffic accident	1/322 (0.3%)	2
Ankle fracture	1/322 (0.3%)	1
Fall	1/322 (0.3%)	3
Head injury	1/322 (0.3%)	1
Post procedural haemorrhage	1/322 (0.3%)	1
Tendon rupture	1/322 (0.3%)	1
Toxicity to various agents	1/322 (0.3%)	1
Investigations
Electroencephalogram	1/322 (0.3%)	1
Heart rate decreased	1/322 (0.3%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder	1/322 (0.3%)	1
Rotator cuff syndrome	1/322 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II	1/322 (0.3%)	1
Cervix carcinoma	1/322 (0.3%)	1
Colon neoplasm	1/322 (0.3%)	1
Metastatic squamous cell carcinoma	1/322 (0.3%)	1
Nervous system disorders
Convulsion	17/322 (5.3%)	19
Status epilepticus	4/322 (1.2%)	6
Syncope	3/322 (0.9%)	3
Postictal state	2/322 (0.6%)	2
Complicated migraine	1/322 (0.3%)	1
Depressed level of consciousness	1/322 (0.3%)	1
Dizziness	1/322 (0.3%)	1
Hydrocephalus	1/322 (0.3%)	1
Transient ischaemic attack	1/322 (0.3%)	1
Brain oedema	1/322 (0.3%)	1
Cerebrovascular accident	1/322 (0.3%)	1
Dyskinesia	1/322 (0.3%)	1
Grand mal convulsion	1/322 (0.3%)	2
Migraine	1/322 (0.3%)	1
Psychiatric disorders
Acute psychosis	1/322 (0.3%)	1
Confusional state	1/322 (0.3%)	1
Delirium	1/322 (0.3%)	1
Suicidal ideation	1/322 (0.3%)	1
Postictal psychosis	1/322 (0.3%)	1
Renal and urinary disorders
Nephrolithiasis	1/322 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/322 (0.3%)	1
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis	1/322 (0.3%)	1
Vascular disorders
Hypotension	1/322 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	238/322 (73.9%)
Gastrointestinal disorders
Nausea	46/322 (14.3%)	68
Vomiting	27/322 (8.4%)	37
Diarrhoea	23/322 (7.1%)	27
General disorders
Fatigue	40/322 (12.4%)	44
Infections and infestations
Upper respiratory tract infection	45/322 (14%)	53
Nasopharyngitis	38/322 (11.8%)	53
Urinary tract infection	20/322 (6.2%)	30
Influenza	19/322 (5.9%)	23
Injury, poisoning and procedural complications
Fall	31/322 (9.6%)	44
Contusion	25/322 (7.8%)	49
Laceration	22/322 (6.8%)	32
Musculoskeletal and connective tissue disorders
Arthralgia	31/322 (9.6%)	41
Back pain	17/322 (5.3%)	18
Nervous system disorders
Dizziness	89/322 (27.6%)	142
Headache	55/322 (17.1%)	81
Convulsion	29/322 (9%)	42
Tremor	26/322 (8.1%)	30
Psychiatric disorders
Anxiety	24/322 (7.5%)	26
Insomnia	20/322 (6.2%)	24
Depression	17/322 (5.3%)	21
Skin and subcutaneous tissue disorders
Rash	20/322 (6.2%)	31

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.