A Multicenter, Open-Label Study To Investigate The Safety And Pharmacokinetics Of Lacosamide In Children With Partial Seizures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00938431
First received: July 2, 2009
Last updated: November 10, 2015
Last verified: November 2015
Results First Received: June 29, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics 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 SP0847 study began recruitment in October 2009. The study ended in July 2014 with 47 subjects enrolled into the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
>=1 Month to <4 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment

Participant Flow:   Overall Study
    >=1 Month to <4 Years (Safety Set)     >=4 Years to <12 Years (Safety Set)     >=12 Years to <=17 Years (Safety Set)  
STARTED     15     23     9  
COMPLETED     9     14     1  
NOT COMPLETED     6     9     8  
Adverse Event                 5                 8                 6  
Lack of Efficacy                 0                 1                 0  
Did not up titrate to 12 mg kg/day                 1                 0                 0  
Dosing compliance issue                 0                 0                 1  
Reached maximum dose early                 0                 0                 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.
The analysis group for Baseline Characteristics is the Safety Set (SS). The SS is all subjects who signed the informed consent form and took at least 1 dose of Lacosamide (LCM) in SP0847.

Reporting Groups
  Description
>=1 Month to <4 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
>=4 Years to <12 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
>=12 Years to <=17 Years (Safety Set) Subjects were classified as belonging to the age group based on their age at time of enrollment
Total Title No text entered.

Baseline Measures
    >=1 Month to <4 Years (Safety Set)     >=4 Years to <12 Years (Safety Set)     >=12 Years to <=17 Years (Safety Set)     Total Title  
Number of Participants  
[units: participants]
  15     23     9     47  
Age  
[units: years]
Mean (Standard Deviation)
       
Age (years)     1.58  (1.02)     7.41  (2.44)     15.15  (1.50)     7.03  (5.12)  
Gender  
[units: Participants]
       
Female     10     9     5     24  
Male     5     14     4     23  
Weight  
[units: kilograms]
Mean (Standard Deviation)
  9.90  (3.31)     26.73  (10.20)     54.10  (10.49)     26.60  (17.64)  
Height  
[units: centimeters]
Mean (Standard Deviation)
  79.64  (11.22)     121.81  (14.86)     158.93  (11.43)     115.46  (31.23)  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  15.27  (2.33)     17.39  (2.68)     21.38  (3.12)     17.48  (3.37)  
Racial Group  
[units: participants]
       
Asian     1     1     0     2  
Black     0     4     3     7  
White     7     18     5     30  
Other/ Mixed     7     0     1     8  
Ethnicity  
[units: participants]
       
Hispanic or Latino     11     7     3     21  
Not Hispanic or Latino     4     16     6     26  



  Outcome Measures
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1.  Primary:   Number of Subjects That Report at Least One Treatment-emergent Adverse Event During the Study (Approximately 13 Weeks)   [ Time Frame: 13 weeks ]

2.  Secondary:   Change in Seizure Frequency From Baseline to End of Treatment   [ Time Frame: From Baseline to End of Treatment (approximately 13 weeks) ]

3.  Secondary:   Caregiver Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination   [ Time Frame: Visit 5 (Day 27/28) or Early Termination ]

4.  Secondary:   Clinical Global Impression of Change Score at Visit 5 (Day 27/28) or Early Termination   [ Time Frame: Visit 5 (Day 27/28) or Early Termination ]

5.  Secondary:   Plasma Ctrough Values for Lacosamide at Day 7   [ Time Frame: Day 7 ]

6.  Secondary:   Plasma Ctrough Values for Lacosamide at Day 28   [ Time Frame: Day 28 ]

7.  Secondary:   Plasma Ctrough Values for Lacosamide at Day 35   [ Time Frame: Day 35 ]

8.  Secondary:   Plasma Ctrough Values for Lacosamide at Day 42   [ Time Frame: Day 42 ]

9.  Secondary:   Plasma Ctrough Values for SPM 12809 at Day 7   [ Time Frame: Day 7 ]

10.  Secondary:   Plasma Ctrough Values for SPM 12809 at Day 28   [ Time Frame: Day 28 ]

11.  Secondary:   Plasma Ctrough Values for SPM 12809 at Day 35   [ Time Frame: Day 35 ]

12.  Secondary:   Plasma Ctrough Values for SPM 12809 at Day 42   [ Time Frame: Day 42 ]


  Serious Adverse Events


  Other Adverse Events


  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: Study Director
Organization: UCB
phone: +1877 822 9493



Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00938431     History of Changes
Other Study ID Numbers: SP0847
2011-001558-27 ( EudraCT Number )
Study First Received: July 2, 2009
Results First Received: June 29, 2015
Last Updated: November 10, 2015
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products