Determine Safety and Efficacy of Long-term Oral Lacosamide in Patients With Partial Seizures

• Sponsor: UCB BIOSCIENCES, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00522275
• Collaborator: (none)
• Enrollment: 308
• Locations: 60
• Arm: 1
• Duration (Months): 60
• Patients Per Site: 5.1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this trial is to determine whether lacosamide is safe and effective for long-term use in patients with partial-seizures from epilepsy

Condition or Disease	Intervention/Treatment	Phase
Partial Epilepsies	Drug: lacosamide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 308 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Extension Trial to Determine Safety and Efficacy of Long-term Oral SPM 927 in Patients With Partial Seizures
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lacosamide Up to 800 mg/day lacosamide (flexible dosing)	Drug: lacosamide; 50mg or 100 mg tablets, up to 800 mg/day given twice daily (BID) throughout the trial

Outcome Measures

Primary Outcome Measures

1. Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [During the Treatment Period (Maximum 6 years)]

   Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

2. Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years) [During the Treatment Period (Maximum 6 years)]

   Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

3. Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years) [During the Treatment Period (Maximum 6 years)]

   Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.

Secondary Outcome Measures

1. Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years) [Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)]

   Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.

2. Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years) [Treatment Period (Maximum 6 years)]

   At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Completion of parent clinical trial for treatment of partial seizures

Exclusion Criteria:

• Receiving any study drug or experimental device other than lacosamide

• Meets withdrawal criteria for parent trial or experiencing ongoing serious adverse event

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States
2		Mobile	Alabama	United States
3		Phoenix	Arizona	United States
4		Little Rock	Arkansas	United States
5		Los Angeles	California	United States
6		San Francisco	California	United States
7		Englewood	Colorado	United States
8		Fairfield	Connecticut	United States
9		Bradenton	Florida	United States
10		Jacksonville	Florida	United States
11		Maitland	Florida	United States
12		Saint Petersburg	Florida	United States
13		Tallahassee	Florida	United States
14		Tampa	Florida	United States
15		Atlanta	Georgia	United States
16		Chicago	Illinois	United States
17		Springfield	Illinois	United States
18		Indianapolis	Indiana	United States
19		Wichita	Kansas	United States
20		Lexington	Kentucky	United States
21		Louisville	Kentucky	United States
22		Baltimore	Maryland	United States
23		Bethesda	Maryland	United States
24		Boston	Massachusetts	United States
25		Golden Valley	Minnesota	United States
26		Saint Cloud	Minnesota	United States
27		Saint Paul	Minnesota	United States
28		Chesterfield	Missouri	United States
29		Somerset	New Jersey	United States
30		Albuquerque	New Mexico	United States
31		Buffalo	New York	United States
32		New York	New York	United States
33		Rochester	New York	United States
34		Syracuse	New York	United States
35		Asheville	North Carolina	United States
36		Durham	North Carolina	United States
37		Greenville	North Carolina	United States
38		Winston-Salem	North Carolina	United States
39		Cincinnati	Ohio	United States
40		Cleveland	Ohio	United States
41		Columbus	Ohio	United States
42		Toledo	Ohio	United States
43		Tulsa	Oklahoma	United States
44		Medford	Oregon	United States
45		Hershey	Pennsylvania	United States
46		Philadelphia	Pennsylvania	United States
47		Providence	Rhode Island	United States
48		Beaufort	South Carolina	United States
49		Charleston	South Carolina	United States
50		Nashville	Tennessee	United States
51		Dallas	Texas	United States
52		San Antonio	Texas	United States
53		Charlottesville	Virginia	United States
54		Newport News	Virginia	United States
55		Norfolk	Virginia	United States
56		Richmond	Virginia	United States
57		Seattle	Washington	United States
58		Morgantown	West Virginia	United States
59		Marshfield	Wisconsin	United States
60		Milwaukee	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:

• FDA Safety Alerts and Recalls
• Product Information

Publications

None provided.

• Responsible Party: UCB BIOSCIENCES, Inc.
• ClinicalTrials.gov Identifier: NCT00522275
• Other Study ID Numbers: SP0756; 2014-004398-18
• First Posted: Aug 29, 2007
• Last Update Posted: Jul 18, 2018
• Last Verified: Jul 1, 2017

• Keywords provided by UCB BIOSCIENCES, Inc.: Adjunctive treatment in epilepsy; add-on treatment for epilepsy; partial seizures; AEDs; antiepileptic drugs; seizures
• Additional relevant MeSH terms: Epilepsy; Seizures; Epilepsies, Partial; Lacosamide

Study Results

Participant Flow

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Period Title: Overall Study
STARTED	308
COMPLETED	138
NOT COMPLETED	170

Baseline Characteristics

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Overall Participants	308
Age (Count of Participants)
<=18 years	6 1.9%
Between 18 and 65 years	295 95.8%
>=65 years	7 2.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	38.2 (12.46)
Sex: Female, Male (Count of Participants)
Female	146 47.4%
Male	162 52.6%
Region of Enrollment (participants) [Number]
United States	308 100%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Description	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame	During the Treatment Period (Maximum 6 years)

Outcome Measure Data

Analysis Population Description

Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Measure Participants	308
Number [subjects]	288

2. Primary Outcome

Title	Number of Subjects Prematurely Discontinuing Due to a Treatment-Emergent Adverse Event (TEAE) During the Treatment Period (Maximum 6 Years)
Description	Adverse events are any untoward medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame	During the Treatment Period (Maximum 6 years)

Outcome Measure Data

Analysis Population Description

Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Measure Participants	308
Number [subjects]	33

3. Primary Outcome

Title	Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (Maximum 6 Years)
Description	Serious adverse events are any untoward serious medical occurrences in a subject administered study treatment, whether or not these events are related to treatment.
Time Frame	During the Treatment Period (Maximum 6 years)

Outcome Measure Data

Analysis Population Description

Of the 308 subjects who entered the study, 308 are included in this summary based on the Safety Set (SS). SS population: number of subjects treated.

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Measure Participants	308
Number [subjects]	71

4. Secondary Outcome

Title	Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (Maximum 6 Years)
Description	Negative changes from Baseline indicate an improvement (i.e., a reduction) in 28-day seizure frequency.
Time Frame	Baseline (8-week Baseline Period from the parent study SP0754 [NCT00136019]), Treatment Period (Maximum 6 years)

Outcome Measure Data

Analysis Population Description

Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Measure Participants	307
Median (Full Range) [percentage change]	-48.5

5. Secondary Outcome

Title	Percentage of at Least 50 % Responders During the Treatment Period (Maximum 6 Years)
Description	At least 50 percent response is based on the percentage reduction in 28-day seizure frequency during the Treatment Period of the open-label extension relative to the Baseline Phase of the prior study.
Time Frame	Treatment Period (Maximum 6 years)

Outcome Measure Data

Analysis Population Description

Of the 308 subjects who were enrolled/treated in the study, 307 are included in this summary based on the Full Analysis Set (FAS). FAS population: number of subjects treated with at least 1 post-baseline seizure diary day with available data during the SP756 study.

Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
Measure Participants	307
Number [percentage of subjects]	48.2

Adverse Events

Time Frame	Maximum of 6 years
Arm/Group Title	Lacosamide
Arm/Group Description	Up to 800 mg/day lacosamide (flexible dosing)
All Cause Mortality
	Lacosamide
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	71/308 (23.1%)
Cardiac disorders
Atrial fibrillation	2/308 (0.6%)	2
Ventricular extrasystoles	2/308 (0.6%)	2
Angina pectoris	1/308 (0.3%)	1
Coronary artery stenosis	1/308 (0.3%)	1
Supraventricular tachycardia	1/308 (0.3%)	1
Cardio-respiratory arrest	1/308 (0.3%)	1
Eye disorders
Diplopia	1/308 (0.3%)	1
Gastrointestinal disorders
Vomiting	4/308 (1.3%)	4
Nausea	2/308 (0.6%)	2
Gastrointestinal haemorrhage	2/308 (0.6%)	2
Dyspepsia	1/308 (0.3%)	1
Small intestinal obstruction	1/308 (0.3%)	1
Abdominal pain	1/308 (0.3%)	2
Haematemesis	1/308 (0.3%)	1
Mesenteric vein thrombosis	1/308 (0.3%)	1
Peptic ulcer	1/308 (0.3%)	1
Rectal haemorrhage	1/308 (0.3%)	1
Gastrooesophagitis	1/308 (0.3%)	1
General disorders
Chest pain	5/308 (1.6%)	6
Asthenia	2/308 (0.6%)	2
Pyrexia	1/308 (0.3%)	1
Hepatobiliary disorders
Cholecystitis	1/308 (0.3%)	1
Chronic hepatitis	1/308 (0.3%)	1
Immune system disorders
Hypersensitivity	1/308 (0.3%)	1
Infections and infestations
Pneumonia	5/308 (1.6%)	5
Cystitis	1/308 (0.3%)	1
Enterobacter pneumonia	1/308 (0.3%)	1
Meningitis viral	1/308 (0.3%)	1
Wound infection	1/308 (0.3%)	1
Influenza	1/308 (0.3%)	1
Salpingitis	1/308 (0.3%)	1
Injury, poisoning and procedural complications
Fall	2/308 (0.6%)	2
Drug toxicity	1/308 (0.3%)	1
Facial bones fracture	1/308 (0.3%)	1
Skin laceration	1/308 (0.3%)	1
Traumatic haematoma	1/308 (0.3%)	1
Excoriation	1/308 (0.3%)	1
Limb injury	1/308 (0.3%)	1
Skull fracture	1/308 (0.3%)	1
Multiple fractures	1/308 (0.3%)	1
Accidental overdose	1/308 (0.3%)	1
Operative haemorrhage	1/308 (0.3%)	1
Subdural haematoma	1/308 (0.3%)	1
Burns third degree	1/308 (0.3%)	1
Hip fracture	1/308 (0.3%)	1
Jaw fracture	1/308 (0.3%)	1
Investigations
Hepatic enzyme increased	1/308 (0.3%)	1
Electrocardiogram QT corrected interval prolonged	1/308 (0.3%)	1
Blood pressure increased	1/308 (0.3%)	1
Metabolism and nutrition disorders
Dehydration	3/308 (1%)	4
Anorexia	1/308 (0.3%)	1
Hyponatraemia	1/308 (0.3%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion	1/308 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer	1/308 (0.3%)	1
Basal cell carcinoma	1/308 (0.3%)	1
Breast cancer	1/308 (0.3%)	1
Nervous system disorders
Convulsion	11/308 (3.6%)	13
Dizziness	4/308 (1.3%)	4
Status epilepticus	3/308 (1%)	3
Coordination abnormal	2/308 (0.6%)	2
Complex partial seizures	1/308 (0.3%)	1
Headache	1/308 (0.3%)	1
Transient ischaemic attack	1/308 (0.3%)	1
Grand mal convulsion	1/308 (0.3%)	1
Myoclonus	1/308 (0.3%)	1
Subarachnoid haemorrhage	1/308 (0.3%)	1
Psychiatric disorders
Mental status changes	3/308 (1%)	3
Suicidal ideation	3/308 (1%)	3
Depression	2/308 (0.6%)	2
Suicide attempt	1/308 (0.3%)	2
Aggression	1/308 (0.3%)	1
Psychotic disorder	1/308 (0.3%)	1
Sleep attacks	1/308 (0.3%)	1
Abnormal behaviour	1/308 (0.3%)	1
Paranoia	1/308 (0.3%)	1
Anxiety	1/308 (0.3%)	1
Renal and urinary disorders
Nephrolithiasis	2/308 (0.6%)	2
Renal failure acute	1/308 (0.3%)	1
Haematuria	1/308 (0.3%)	1
Renal failure	1/308 (0.3%)	1
Reproductive system and breast disorders
Ovarian cyst	2/308 (0.6%)	2
Priapism	1/308 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Pneumothorax	2/308 (0.6%)	2
Pulmonary oedema	1/308 (0.3%)	1
Haemoptysis	1/308 (0.3%)	2
Skin and subcutaneous tissue disorders
Angioneurotic oedema	1/308 (0.3%)	1
Surgical and medical procedures
Vagal nerve stimulator implantation	1/308 (0.3%)	1
Vascular disorders
Thrombosis	1/308 (0.3%)	1
Other (Not Including Serious) Adverse Events
	Lacosamide
	Affected / at Risk (%)	# Events
Total	265/308 (86%)
Eye disorders
Diplopia	46/308 (14.9%)	72
Vision blurred	28/308 (9.1%)	39
Gastrointestinal disorders
Nausea	56/308 (18.2%)	78
Vomiting	47/308 (15.3%)	66
Diarrhoea	25/308 (8.1%)	32
Constipation	22/308 (7.1%)	22
General disorders
Fatigue	36/308 (11.7%)	45
Irritability	19/308 (6.2%)	21
Gait disturbance	18/308 (5.8%)	22
Infections and infestations
Nasopharyngitis	53/308 (17.2%)	83
Upper respiratory tract infection	40/308 (13%)	54
Sinusitis	32/308 (10.4%)	46
Influenza	26/308 (8.4%)	28
Urinary tract infection	25/308 (8.1%)	37
Bronchitis	17/308 (5.5%)	23
Injury, poisoning and procedural complications
Contusion	57/308 (18.5%)	90
Fall	47/308 (15.3%)	93
Skin laceration	38/308 (12.3%)	69
Joint sprain	19/308 (6.2%)	20
Excoriation	18/308 (5.8%)	38
Head injury	17/308 (5.5%)	21
Investigations
Weight increased	17/308 (5.5%)	17
Gamma-glutamyltransferase increased	17/308 (5.5%)	17
Musculoskeletal and connective tissue disorders
Back pain	34/308 (11%)	46
Arthralgia	18/308 (5.8%)	26
Pain in extremity	16/308 (5.2%)	24
Nervous system disorders
Dizziness	154/308 (50%)	260
Headache	67/308 (21.8%)	91
Convulsion	44/308 (14.3%)	62
Tremor	41/308 (13.3%)	57
Balance disorder	41/308 (13.3%)	51
Nystagmus	34/308 (11%)	37
Coordination abnormal	26/308 (8.4%)	30
Somnolence	25/308 (8.1%)	28
Memory impairment	20/308 (6.5%)	21
Psychiatric disorders
Depression	35/308 (11.4%)	45
Insomnia	28/308 (9.1%)	38
Anxiety	17/308 (5.5%)	20
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain	27/308 (8.8%)	29
Cough	20/308 (6.5%)	23
Skin and subcutaneous tissue disorders
Rash	20/308 (6.5%)	21

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.