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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions:	Partial Epilepsies; Partial Onset Seizures
Intervention:	Drug: lacosamide

  Participant Flow

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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

  Baseline Characteristics

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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]; Count of Participants
<=18 years	0 0.0%	2 4.0%	0 0.0%	2 2.0%
Between 18 and 65 years	25 100.0%	48 96.0%	25 100.0%	98 98.0%
>=65 years	0 0.0%	0 0.0%	0 0.0%	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)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	14 56.0%	26 52.0%	9 36.0%	49 49.0%
Male	11 44.0%	24 48.0%	16 64.0%	51 51.0%
Region of Enrollment; [Units: Participants]
United States	25	50	25	100

  Outcome Measures

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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) ]

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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) ]

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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 ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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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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  More Information

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Certain Agreements:  

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: 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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. 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. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.; Restriction Description: UCB has > 60 days 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 results shall be published regardless of outcome.

Results Point of Contact:  

Name/Title: UCB Clinical Trial Call Center
Organization: UCB, Inc
phone: +1 877 822 9493

Publications of Results:

Fountain NB, Krauss G, Isojarvi J, Dilley D, Doty P, Rudd GD. Safety and tolerability of adjunctive lacosamide intravenous loading dose in lacosamide-naive patients with partial-onset seizures. Epilepsia. 2013 Jan;54(1):58-65. doi: 10.1111/j.1528-1167.2012.03543.x. Epub 2012 Jun 18.

Responsible Party:	UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:	NCT00655551 History of Changes
Other Study ID Numbers:	SP0925; 2014-004378-40 ( EudraCT Number )
First Submitted:	March 26, 2008
First Posted:	April 10, 2008
Results First Submitted:	September 23, 2010
Results First Posted:	October 20, 2010
Last Update Posted:	August 28, 2017