Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
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 


  Outcome Measures
  Show All Outcome Measures

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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