Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Lacosamide (200 mg)	Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Lacosamide (300 mg)	Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Lacosamide (400 mg)	Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily

Participant Flow for 5 periods

Period 1:   All Periods Combined

	Lacosamide (200 mg)	Lacosamide (300 mg)	Lacosamide (400 mg)
STARTED	25	50	25
COMPLETED	25	47	21
NOT COMPLETED	0	3	4
Adverse Event	0	3	4

Period 2:   Period 1 (up to 7 Days)

	Lacosamide (200 mg)	Lacosamide (300 mg)	Lacosamide (400 mg)
STARTED	25	0	0
COMPLETED	25	0	0
NOT COMPLETED	0	0	0

Period 3:   Period 2 (up to 7 Days)

	Lacosamide (200 mg)	Lacosamide (300 mg)	Lacosamide (400 mg)
STARTED	0	25	0
COMPLETED	0	24	0
NOT COMPLETED	0	1	0
Adverse Event	0	1	0

Period 4:   Period 3 (up to 7 Days)

	Lacosamide (200 mg)	Lacosamide (300 mg)	Lacosamide (400 mg)
STARTED	0	0	25
COMPLETED	0	0	21
NOT COMPLETED	0	0	4
Adverse Event	0	0	4

Period 5:   Period 4 (up to 7 Days)

	Lacosamide (200 mg)	Lacosamide (300 mg)	Lacosamide (400 mg)
STARTED	0	25	0
COMPLETED	0	23	0
NOT COMPLETED	0	2	0
Adverse Event	0	2	0

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Lacosamide (200 mg)	Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily
Lacosamide (300 mg)	Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily
Lacosamide (400 mg)	Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily
Total	Total of all reporting groups

Baseline Measures

	Lacosamide (200 mg)	Lacosamide (300 mg)	Lacosamide (400 mg)	Total
Overall Participants Analyzed  [Units: Participants]	25	50	25	100
Age  [Units: Participants]
<=18 years	0	2	0	2
Between 18 and 65 years	25	48	25	98
>=65 years	0	0	0	0
Age  [Units: Years] Mean (Standard Deviation)	39.1  (11.77)	38.6  (11.53)	39.6  (12.24)	39.0  (11.66)
Gender  [Units: Participants]
Female	14	26	9	49
Male	11	24	16	51
Region of Enrollment  [Units: Participants]
United States	25	50	25	100

1.  Primary:

Number of Subjects With at Least One Adverse Event During the Treatment Period (up to 7 Days)   [ Time Frame: Treatment period (up to 7 days) ]

2.  Primary:

Number of Subjects Who Withdrew From the Trial Due to an Adverse Event   [ Time Frame: Entire trial period (up to 6 weeks), screening through safety follow-up period (2 weeks post last medication) ]

3.  Secondary:

Number of Subjects With at Least One Adverse Event With an Onset Within 4 Hours of Start of Infusion   [ Time Frame: 0-4 hours post start of the infusion ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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