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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: June 16, 2015
Last verified: June 2015
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
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  



  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.
No text entered.

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) ]
  Show Outcome Measure 1

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) ]
  Show Outcome Measure 2

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) ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5


  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:
unchecked 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.
unchecked 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.


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


Publications of Results:


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00515619     History of Changes
Other Study ID Numbers: SP0774
2004-000152-16 ( EudraCT Number )
Study First Received: August 13, 2007
Results First Received: August 5, 2011
Last Updated: June 16, 2015
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