Assess Safety and Efficacy of Lacosamide in Patients With Partial Seizures

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB Pharma

ClinicalTrials.gov Identifier:

NCT00515619

First received: August 13, 2007

Last updated: September 19, 2014

Last verified: August 2011

History of Changes

Results First Received: August 5, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; 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 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
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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)

Participant Flow: Overall Study

	Lacosamide
STARTED	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

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	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
Number of Participants [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

Outcome Measures

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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) ]

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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) ]

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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) ]

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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) ]

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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) ]

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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 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.

Results Point of Contact:

Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
phone: +1 887 822 9493

No publications provided

Responsible Party:	UCB Pharma
ClinicalTrials.gov Identifier:	NCT00515619 History of Changes
Other Study ID Numbers:	SP0774, 2004-000152-16
Study First Received:	August 13, 2007
Results First Received:	August 5, 2011
Last Updated:	September 19, 2014
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Lithuania: State Medicine Control Agency - Ministry of Health Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation Spain: Spanish Agency of Medicines Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

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