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Open-Label Study to Assess Lacosamide Safety as Add-on Therapy for Primary Generalized Tonic-Clonic Seizures in Subjects With Epilepsy

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ClinicalTrials.gov Identifier: NCT01118949
Recruitment Status : Completed
First Posted : May 7, 2010
Results First Posted : September 7, 2012
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 49
Recruitment Details Safety Set (SS) includes all enrolled subjects who took at least 1 dose of Lacosamide (LCM).
Pre-assignment Details Participant Flow and Baseline Characteristics refer to the Safety Set (SS).
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Period Title: Overall Study
Started 49
Completed 40
Not Completed 9
Reason Not Completed
Adverse Event             5
Withdrawal by Subject             4
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
3
   6.1%
Between 18 and 65 years
46
  93.9%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
29.7  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
36
  73.5%
Male
13
  26.5%
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 49 participants
168.08  (9.32)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 49 participants
77.90  (19.80)
1.Primary Outcome
Title Change in the Number of Seizure Days With Absence Seizures From the Baseline Phase to the Maintenance Phase
Hide Description

During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:

  • Seizure type
  • Seizure frequency

A negative value in change of seizure days with absence seizures shows a decrease in seizure days with absence seizures.

Time Frame From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: number of seizure days
-0.37  (4.8)
2.Primary Outcome
Title Change in the Number of Seizure Days With Myoclonic Seizures From the Baseline Phase to the Maintenance Phase
Hide Description

During the study subjects kept a diary to record daily seizure activity from Visit 1 until the end of study participation. The following information has been recorded:

  • Seizure type
  • Seizure frequency

A negative value in change of seizure days with myoclonic seizures shows a decrease in seizure days with myoclonic seizures.

Time Frame From Baseline Phase (Weeks 0 to 4) to Maintenance Phase (Weeks 8 to 13)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 49 subjects in the Safety Set (SS), 44 are included in this analysis. Data not available for 5 subjects.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: number of seizure days
-2.19  (5.80)
3.Secondary Outcome
Title Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Hide Description Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The general spike-wave discharges are calculated per interpretable hours.
Time Frame From Visit 2 (Week 4) to Visit 6 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: 1/hour
-3.47  (55.85)
4.Secondary Outcome
Title Changes in Count of 3 Hertz (Hz) Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 (Baseline Phase) to Visit 6 (Maintenance Phase)
Hide Description Subjects were asked to return to the clinic on the morning of the day prior to Visit 2 and Visit 6 to begin 24-hour ambulatory EEG recordings for evaluation of spike-wave discharges. Only subjects with an evaluable EEG measurement with > 19 interpretable hours at Visit 2 and Visit 6 are included in this analysis. The 3 Hertz (Hz) spike-wave discharges are calculated per awake hours.
Time Frame From Visit 2 (Week 4) to Visit 6 (Week 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 49 subjects in the Safety Set (SS), 40 subjects are included in this analysis. Data not available for 9 subjects.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Participants Analyzed 40
Mean (Standard Deviation)
Unit of Measure: 1/hour
0.13  (2.17)
5.Secondary Outcome
Title Number of Subjects With Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame From Visit 2 (Week 4) to Visit 7 (Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All 49 subjects in the Safety Set (SS) are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
43
6.Secondary Outcome
Title Number of Subjects Withdrawn From the Study Due to Treatment Emergent Adverse Events (TEAEs) During the 10-week Treatment Period
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment.
Time Frame From Visit 2 (Week 4) to Visit 7 (Week 13)
Hide Outcome Measure Data
Hide Analysis Population Description
All 49 subjects in the Safety Set (SS) are included in this analysis.
Arm/Group Title Lacosamide
Hide Arm/Group Description:
Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: participants
5
Time Frame Adverse Events were collected up to 16 weeks from Baseline (Week 0 - Week 4) over the 3-weeks Titration Period (Week 4 - Week 7) and the 6-weeks Maintenance Period (Week 7 - Week 13) to the Final Clinic Visit at the end of Week 16.
Adverse Event Reporting Description Adverse Events refer to the Safety Set (SS). SS includes all enrolled subjects who received at least one dose of trial medication.
 
Arm/Group Title Lacosamide
Hide Arm/Group Description Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
All-Cause Mortality
Lacosamide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lacosamide
Affected / at Risk (%) # Events
Total   1/49 (2.04%)    
Nervous system disorders   
Petit mal epilepsy * 1  1/49 (2.04%)  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   39/49 (79.59%)    
Eye disorders   
Diplopia * 1  4/49 (8.16%)  4
Gastrointestinal disorders   
Nausea * 1  13/49 (26.53%)  15
Vomiting * 1  7/49 (14.29%)  9
General disorders   
Fatigue * 1  6/49 (12.24%)  6
Gait Disturbance * 1  5/49 (10.20%)  5
Chills * 1  4/49 (8.16%)  5
Injury, poisoning and procedural complications   
Contusion * 1  3/49 (6.12%)  4
Nervous system disorders   
Dizziness * 1  19/49 (38.78%)  27
Headache * 1  8/49 (16.33%)  8
Somnolence * 1  8/49 (16.33%)  8
Tremor * 1  6/49 (12.24%)  8
Migraine * 1  4/49 (8.16%)  4
Petit mal epilepsy * 1  4/49 (8.16%)  4
Psychiatric disorders   
Insomnia * 1  6/49 (12.24%)  6
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  4/49 (8.16%)  4
Skin and subcutaneous tissue disorders   
Pruritus * 1  3/49 (6.12%)  3
*
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB BIOSCIENCES, Inc. )
ClinicalTrials.gov Identifier: NCT01118949     History of Changes
Other Study ID Numbers: SP0961
2014-004379-22 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 7, 2010
Results First Submitted: August 8, 2012
Results First Posted: September 7, 2012
Last Update Posted: July 17, 2018