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Open-Label Extension Study to Assess the Safety and Seizure Frequency Associated With Lacosamide for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

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ClinicalTrials.gov Identifier: NCT01118962
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : December 4, 2013
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 39
Recruitment Details

This study began enrollment in August 2010. The study completed in October 2012. The participant flow consists of the Safety Set (SS).

The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).

Pre-assignment Details  
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).

Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

Period Title: Overall Study
Started 39
Completed 29
Not Completed 10
Reason Not Completed
Adverse Event             2
Lack of Efficacy             1
Protocol Violation             1
Withdrawal by Subject             4
Pregnancy             1
Non-compliance with Medicinal Product             1
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).

Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
Baseline measurements consist of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
3
   7.7%
Between 18 and 65 years
36
  92.3%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 39 participants
30.3  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
28
  71.8%
Male
11
  28.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 39 participants
77.66  (17.58)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 39 participants
167.88  (8.25)
1.Primary Outcome
Title Number of Participants With Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
Hide Description [Not Specified]
Time Frame From Visit 1 to the end of study (Approximately 61 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.

The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).

Arm/Group Title Lacosamide
Hide Arm/Group Description:

Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).

Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
37
2.Primary Outcome
Title Number of Participants Withdrawn From the Study Due to Treatment-emergent Adverse Events (TEAEs) From Visit 1 to the End of Study (Approximately 61 Weeks)
Hide Description [Not Specified]
Time Frame From Visit 1 to the end of study (Approximately 61 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Of the 39 subjects in the Safety Set (SS), 39 were included in this analysis.

The SS consists of all subjects that were dosed at least once with Lacosamide (LCM).

Arm/Group Title Lacosamide
Hide Arm/Group Description:

Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).

Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: participants
2
Time Frame Adverse Events were collected from August 2010 through October 2012. Adverse Event reporting consists of the Safety Set (SS). The Safety Set consists of all subjects that were dosed at least once with Lacosamide (LCM).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lacosamide
Hide Arm/Group Description

Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).

Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses.

All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   3/39 (7.69%)    
Infections and infestations   
PNEUMONIA * 1  1/39 (2.56%)  1
Nervous system disorders   
CONVULSION * 1  1/39 (2.56%)  1
MIGRAINE * 1  1/39 (2.56%)  1
Psychiatric disorders   
ABNORMAL BEHAVIOUR * 1  1/39 (2.56%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide
Affected / at Risk (%) # Events
Total   35/39 (89.74%)    
Cardiac disorders   
PALPITATIONS * 1  2/39 (5.13%)  2
Eye disorders   
DIPLOPIA * 1  3/39 (7.69%)  4
Gastrointestinal disorders   
NAUSEA * 1  5/39 (12.82%)  5
DIARRHOEA * 1  2/39 (5.13%)  2
General disorders   
FATIGUE * 1  3/39 (7.69%)  4
GAIT DISTURBANCE * 1  2/39 (5.13%)  2
Immune system disorders   
SEASONAL ALLERGY * 1  3/39 (7.69%)  3
Infections and infestations   
UPPER RESPIRATORY TRACT INFECTION * 1  10/39 (25.64%)  13
SINUSITIS * 1  3/39 (7.69%)  3
GASTROENTERITIS VIRAL * 1  2/39 (5.13%)  3
INFLUENZA * 1  2/39 (5.13%)  2
TOOTH ABSCESS * 1  2/39 (5.13%)  2
Injury, poisoning and procedural complications   
FALL * 1  4/39 (10.26%)  4
JOINT SPRAIN * 1  4/39 (10.26%)  5
CONTUSION * 1  3/39 (7.69%)  3
EXCORIATION * 1  2/39 (5.13%)  2
MUSCLE STRAIN * 1  2/39 (5.13%)  2
SKIN LACERATION * 1  2/39 (5.13%)  2
Investigations   
WEIGHT INCREASED * 1  4/39 (10.26%)  4
ALANINE AMINOTRANSFERASE INCREASED * 1  2/39 (5.13%)  2
ARTERIAL BRUIT * 1  2/39 (5.13%)  2
ASPARTATE AMINOTRANSFERASE INCREASED * 1  2/39 (5.13%)  2
GAMMA-GLUTAMYLTRANSFERASE INCREASED * 1  2/39 (5.13%)  2
Metabolism and nutrition disorders   
INCREASED APPETITE * 1  2/39 (5.13%)  2
Musculoskeletal and connective tissue disorders   
MUSCULOSKELETAL PAIN * 1  3/39 (7.69%)  3
ARTHRALGIA * 1  2/39 (5.13%)  4
Nervous system disorders   
DIZZINESS * 1  10/39 (25.64%)  12
HEADACHE * 1  7/39 (17.95%)  12
TREMOR * 1  6/39 (15.38%)  6
POSTICTAL STATE * 1  2/39 (5.13%)  9
Psychiatric disorders   
ANXIETY * 1  4/39 (10.26%)  5
CONFUSIONAL STATE * 1  4/39 (10.26%)  4
DEPRESSION * 1  2/39 (5.13%)  2
Respiratory, thoracic and mediastinal disorders   
DYSPNOEA * 1  4/39 (10.26%)  4
RESPIRATORY DISORDER * 1  2/39 (5.13%)  2
Skin and subcutaneous tissue disorders   
ALOPECIA * 1  2/39 (5.13%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (9.1)
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.
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
Layout table for Results Point of Contact information
Name/Title: UCB (Study Director)
Organization: UCB Clinical Trial Call Center
Phone: +1 887 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01118962     History of Changes
Other Study ID Numbers: SP0962
2014-004375-23 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: October 7, 2013
Results First Posted: December 4, 2013
Last Update Posted: July 17, 2018