Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was started in December of 2004 with recruitment occurring in Australia, Croatia, Czech Republic, Finland, France, Germany, Hungary, Lithuania, Poland, Russia, Spain, Sweden, and the United Kingdom. The study had last patient last visit in August of 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Safety Set consists of all subjects who received at least 1 dose of Lacosamide.

Reporting Groups

	Description
Lacosamide	50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)

Participant Flow:   Overall Study

	Lacosamide
STARTED	376
Safety Set	376
COMPLETED	160
NOT COMPLETED	216
Adverse Event	34
Lack of Efficacy	92
Withdrawal by Subject	66
Protocol Violation	3
Lost to Follow-up	4
Unsatisfactory compliance	6
Other: Site discontinuing trials	2
Other: Subject cannot attend visits	2
Other: Subject required surgery	1
Other: Subject moved to another country	1
Other: Investigator decision	1
Other: Subject became pregnant	1
Other: Request from sponsor	1
Other: Drug available on license	1
Other: Subject interested in other AED	1

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	50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)

Baseline Measures

	Lacosamide
Overall Participants Analyzed  [Units: Participants]	376
Age  [Units: Participants]
<=18 years	7
Between 18 and 65 years	366
>=65 years	3
Age  [Units: Years] Mean (Standard Deviation)	37.8  (11.53)
Gender  [Units: Participants]
Female	169
Male	207
Region of Enrollment  [Units: Participants]
Finland	16
Spain	26
Lithuania	42
Russian Federation	31
United Kingdom	20
France	10
Czech Republic	50
Hungary	31
Poland	37
Croatia	31
Australia	31
Germany	35
Sweden	16

1.  Primary:

Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)   [ Time Frame: During the Treatment Period (up to 5.5 years) ]

2.  Primary:

Number of Subjects Prematurely Discontinuing Due to a Treatment-emergent Adverse Event (TEAE) During the Treatment Period (up to 5.5 Years)   [ Time Frame: During the Treatment Period (up to 5.5 years) ]

3.  Primary:

Number of Subjects Reporting at Least 1 Serious Adverse Event (SAE) During the Treatment Period (up to 5.5 Years)   [ Time Frame: During the Treatment Period (up to 5.5 years) ]

4.  Secondary:

Median Percentage Change From Baseline in 28-day Seizure Frequency During the Treatment Period (up to 5.5 Years)   [ Time Frame: Baseline, Treatment Period (up to 5.5 years) ]

5.  Secondary:

Percentage of at Least 50% Responders During the Treatment Period (up to 5.5 Years)   [ Time Frame: Treatment Period (up to 5.5 years) ]

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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