Trial to Demonstrate the Efficacy and Safety of Conversion to Lacosamide Monotherapy for Partial-onset Seizures (ALEX-MT)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition:	Epilepsy
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
The study was conducted at 160 sites in the United States of America (USA), Canada, Europe, and Australia.The maximum duration of a subject’s trial participation is 30 weeks. The Participant Flow refers to the Safety Set (SS) population which consists of all patients who received at least one dose of study medication.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Reporting Groups

	Description
Lacosamide 300 mg/Day	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Lacosamide 400 mg/Day	Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.

Participant Flow:   Overall Study

	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day
STARTED	106	319 [1]
COMPLETED	69	194
NOT COMPLETED	37	125
Adverse Event	16	56
Lack of Efficacy	11	30
Withdrawal by Subject	0	11
Protocol Violation	2	15
Unsatisfactory compliance of subject	4	3
Lost to Follow-up	4	4
Other reasons for premature termination	0	6

[1]	One subject was randomized at 2 sites and excluded from the Safety Set.

  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.
The Baseline Analysis Population refers to the Safety Set (SS) which includes the unique randomized subjects who took at least one dose of study medication.

Reporting Groups

	Description
Lacosamide 300 mg/Day	Lacosamide 300 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Lacosamide 400 mg/Day	Lacosamide 400 mg/day Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks. Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control.
Total	Total of all reporting groups

Baseline Measures

	Lacosamide 300 mg/Day	Lacosamide 400 mg/Day	Total
Overall Participants Analyzed; [Units: Participants]	106	319	425
Age; [Units: Participants]; Count of Participants
<=18 years	3 2.8%	7 2.2%	10 2.4%
Between 18 and 65 years	99 93.4%	303 95.0%	402 94.6%
>=65 years	4 3.8%	9 2.8%	13 3.1%
Age; [Units: Years]; Mean (Standard Deviation)	41.4 (14.3)	40.4 (12.5)	40.6 (13.0)
Sex: Female, Male; [Units: Participants]; Count of Participants
Female	50 47.2%	169 53.0%	219 51.5%
Male	56 52.8%	150 47.0%	206 48.5%
Race/Ethnicity, Customized; [Units: Participants]
White	91	246	337
Black	9	53	62
Asian	0	1	1
Other	6	19	25
Height; [Units: Centimeter]; Mean (Standard Deviation)	169.72 (10.69)	169.01 (10.87)	169.19 (10.82)
Weight; [Units: Kilogram]; Mean (Standard Deviation)	81.62 (19.53)	82.13 (21.30)	82.00 (20.85)
Body Mass Index (BMI); [Units: Kg/m^2]; Mean (Standard Deviation)	28.22 (5.74)	28.67 (6.64)	28.56 (6.42)
Average Baseline Seizure Frequency per 28 days; [Units: Seizures/28 days]; Mean (Standard Deviation)	10.10 (8.82)	10.22 (8.88)	10.19 (8.86)

  Outcome Measures

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1. Primary:

Percentage of Subjects (Using Kaplan-Meier) Who Are Identified As Meeting At Least 1 Pre-defined Exit Criteria By Day 112 Relative To The Start of Withdrawal of Background Antiepileptic Drug(s) [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]

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2. Secondary:

Time to First Occurrence of Any Exit Event During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]

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3. Secondary:

Percentage of Subjects (Using Kaplan-Meier) Who Are Identified as Meeting at Least 1 Pre-defined Exit Criteria by Day 112, Withdrew Due to Adverse Event (AE) or Withdrew Due to Lack of Efficacy During The Maintenance Period [ Time Frame: 16 Weeks Maintenance Period (approximately 112 days) ]

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4. Secondary:

Duration of Monotherapy Treatment During the Monotherapy Phase of The Maintenance Period (Visit 9 - Visit 12) [ Time Frame: Visit 9 - Visit 12 (approximately 10 weeks) ]

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5. Secondary:

Clinical Global Impression of Change (CGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ]

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6. Secondary:

Patient's Global Impression of Change (PGIC) From Baseline To Last Visit [ Time Frame: Baseline; Last Visit (approximately 27 weeks) ]

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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.

Results Point of Contact:  

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wechsler RT, Li G, French J, O'Brien TJ, D'Cruz O, Williams P, Goodson R, Brock M; ALEX-MT Study Group. Conversion to lacosamide monotherapy in the treatment of focal epilepsy: results from a historical-controlled, multicenter, double-blind study. Epilepsia. 2014 Jul;55(7):1088-98. doi: 10.1111/epi.12681. Epub 2014 Jun 10.

Responsible Party:	UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier:	NCT00520741 History of Changes
Obsolete Identifiers:	NCT01058954
Other Study ID Numbers:	SP0902; 2007-005439-27 ( EudraCT Number )
First Submitted:	August 24, 2007
First Posted:	August 27, 2007
Results First Submitted:	November 26, 2013
Results First Posted:	April 23, 2014
Last Update Posted:	August 28, 2017