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Trial record 1 of 1 for:    NCT01969851
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A Study to Investigate the Safety and Efficacy of Lacosamide Added to the Patients Current Therapy in Patients Aged 1 Month to Less Than 18 Years Old With Epilepsy Syndromes Associated With Generalized Seizures.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01969851
Recruitment Status : Completed
First Posted : October 25, 2013
Results First Posted : May 7, 2019
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Epilepsy
Intervention Drug: Lacosamide
Enrollment 55
Recruitment Details The study started to enroll patients in February 2014 and concluded in April 2018.
Pre-assignment Details The Participant Flow refers to the Safety Set which consisted of all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Arm/Group Title Lacosamide 1 Month - <4 Years Lacosamide 4 Years - <12 Years Lacosamide 12 Years - <18 Years
Hide Arm/Group Description Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Period Title: Overall Study
Started 10 24 21
Completed 9 21 14
Not Completed 1 3 7
Reason Not Completed
Adverse Event             0             0             3
Lack of Efficacy             0             3             1
Withdrawal by Subject             1             0             1
No effective dose in Titration period             0             0             1
Sponsor decision             0             0             1
Arm/Group Title Lacosamide 1 Month - <4 Years Lacosamide 4 Years - <12 Years Lacosamide 12 Years - <18 Years Total Title
Hide Arm/Group Description Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. [Not Specified]
Overall Number of Baseline Participants 10 24 21 55
Hide Baseline Analysis Population Description
The Baseline Characteristics refer to the Safety Set which consisted of all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 21 participants 55 participants
<=18 years
10
 100.0%
24
 100.0%
21
 100.0%
55
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 24 participants 21 participants 55 participants
2.716  (0.765) 6.969  (1.998) 14.753  (1.766) 9.168  (4.994)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 21 participants 55 participants
Female
0
   0.0%
9
  37.5%
15
  71.4%
24
  43.6%
Male
10
 100.0%
15
  62.5%
6
  28.6%
31
  56.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 24 participants 21 participants 55 participants
American Indian or Alaska Native
0
   0.0%
1
   4.2%
1
   4.8%
2
   3.6%
Black or African American
0
   0.0%
2
   8.3%
1
   4.8%
3
   5.5%
White
7
  70.0%
18
  75.0%
11
  52.4%
36
  65.5%
More than one race
3
  30.0%
3
  12.5%
7
  33.3%
13
  23.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   4.8%
1
   1.8%
1.Primary Outcome
Title Mean Changes in Count of Generalized Spike-wave Discharges on 24-hour Ambulatory Electroencephalogram (EEG) From Visit 2 to Visit 6
Hide Description The mean change in the count of generalized spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Time Frame From Baseline (Day 1) to Visit 6 (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Arm/Group Title Lacosamide 1 Month - <4 Years SS Lacosamide 4 Years - <2 Years SS Lacosamide 12 Years - <18 Years SS
Hide Arm/Group Description:
Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Overall Number of Participants Analyzed 9 22 14
Mean (Standard Deviation)
Unit of Measure: discharges
-4.55  (257.32) -166.22  (447.80) -203.12  (432.42)
2.Primary Outcome
Title Mean Change in Days With Any Generalized Seizures (Absence, Myoclonic, Clonic, Tonic, Tonic-clonic, Atonic, Partial Evolving to Secondarily Generalized) Per 28 Days From the Baseline Period to the Maintenance Period (Approximately 24 Weeks)
Hide Description The mean change in the count of days with generalized seizures was presented.
Time Frame Baseline Period to the Maintenance Period (approximately 24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Arm/Group Title Lacosamide 1 Month - <4 Years SS Lacosamide 4 Years - <2 Years SS Lacosamide 12 Years - <18 Years SS
Hide Arm/Group Description:
Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Overall Number of Participants Analyzed 10 23 20
Mean (Standard Deviation)
Unit of Measure: days
0.50  (6.63) -1.90  (3.76) -3.38  (6.42)
3.Secondary Outcome
Title Mean Changes in Count of 3 Hz Spike-wave Discharges (During Waking Hours) on 24-hour Ambulatory EEG From Visit 2 to Visit 6
Hide Description The mean change in the count of 3 Hertz (Hz) spike-wave discharges was presented. Visit 6 (Week 6) was the End of the Titration Period.
Time Frame From Baseline (Day 1) to Visit 6 (Week 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Arm/Group Title Lacosamide 1 Month - <4 Years SS Lacosamide 4 Years - <2 Years SS Lacosamide 12 Years - <18 Years SS
Hide Arm/Group Description:
Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Overall Number of Participants Analyzed 9 22 14
Mean (Standard Deviation)
Unit of Measure: count of discharges
-0.14  (0.42) -1.60  (9.92) 0.00  (0.00)
4.Secondary Outcome
Title Number of Subject Withdrawals Due to Adverse Events From Baseline to End of Study (Approximately 32 Weeks)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame From Baseline to End of Study (approximately 32 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Arm/Group Title Lacosamide 1 Month - <4 Years SS Lacosamide 4 Years - <2 Years SS Lacosamide 12 Years - <18 Years SS
Hide Arm/Group Description:
Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Overall Number of Participants Analyzed 10 24 21
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
3
  14.3%
5.Secondary Outcome
Title Number of Subjects Experiencing at Least 1 Treatment-emergent Adverse Event From Baseline to End of Study (Approximately 32 Weeks)
Hide Description An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that does not necessarily have a causal relationship with this treatment.
Time Frame From Baseline to End of Study (approximately 32 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Set (SS) included all enrolled subjects who took at least 1 dose of lacosamide (LCM).
Arm/Group Title Lacosamide 1 Month - <4 Years SS Lacosamide 4 Years - <2 Years SS Lacosamide 12 Years - <18 Years SS
Hide Arm/Group Description:
Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
Overall Number of Participants Analyzed 10 24 21
Measure Type: Count of Participants
Unit of Measure: Participants
10
 100.0%
21
  87.5%
18
  85.7%
Time Frame Adverse events were collected throughout the study (up to week 26)
Adverse Event Reporting Description An Adverse Event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product that did not necessarily have a causal relationship with this treatment.
 
Arm/Group Title Lacosamide 1 Month - <4 Years Lacosamide 4 Years - <12 Years Lacosamide 12 Years - <18 Years
Hide Arm/Group Description Subjects, aged 1 month to <4 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50 kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. Subjects, aged 4 years to <12 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg. Subjects, aged 12 years to <18 years, who were administered Lacosamide oral solution (for subjects weighing <50 kg) or tablet (for subjects weighing >=50 kg). The initial dose of 2 mg/kg/day (for subjects weighing <50 kg), or 100 mg/day (for subjects weighing >=50 kg) was titrated to optimize tolerability and seizure control to at least 4 mg/kg/day for subjects weighing <50kg, or 200 mg/day for subjects weighing >=50 kg; not to exceed 12 mg/kg/day for subjects weighing <50 kg, or 600 mg/day in subjects weighing >=50 kg.
All-Cause Mortality
Lacosamide 1 Month - <4 Years Lacosamide 4 Years - <12 Years Lacosamide 12 Years - <18 Years
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/24 (0.00%)      0/21 (0.00%)    
Hide Serious Adverse Events
Lacosamide 1 Month - <4 Years Lacosamide 4 Years - <12 Years Lacosamide 12 Years - <18 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/24 (0.00%)      1/21 (4.76%)    
Infections and infestations       
Oral herpes * 1  0/10 (0.00%)  0 0/24 (0.00%)  0 1/21 (4.76%)  1
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lacosamide 1 Month - <4 Years Lacosamide 4 Years - <12 Years Lacosamide 12 Years - <18 Years
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/10 (100.00%)      19/24 (79.17%)      15/21 (71.43%)    
Gastrointestinal disorders       
Vomiting * 1  0/10 (0.00%)  0 4/24 (16.67%)  5 1/21 (4.76%)  1
Diarrhoea * 1  1/10 (10.00%)  1 0/24 (0.00%)  0 2/21 (9.52%)  2
General disorders       
Pyrexia * 1  4/10 (40.00%)  5 6/24 (25.00%)  7 3/21 (14.29%)  3
Irritability * 1  1/10 (10.00%)  1 1/24 (4.17%)  2 1/21 (4.76%)  1
Infections and infestations       
Nasopharyngitis * 1  5/10 (50.00%)  7 1/24 (4.17%)  1 3/21 (14.29%)  3
Pharyngotonsillitis * 1  2/10 (20.00%)  2 1/24 (4.17%)  2 3/21 (14.29%)  3
Upper respiratory tract infection * 1  0/10 (0.00%)  0 4/24 (16.67%)  4 2/21 (9.52%)  2
Bronchitis * 1  1/10 (10.00%)  1 2/24 (8.33%)  2 2/21 (9.52%)  3
Pharyngitis * 1  0/10 (0.00%)  0 3/24 (12.50%)  3 1/21 (4.76%)  1
Ear infection * 1  1/10 (10.00%)  3 2/24 (8.33%)  2 0/21 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite * 1  2/10 (20.00%)  2 0/24 (0.00%)  0 2/21 (9.52%)  2
Nervous system disorders       
Somnolence * 1  4/10 (40.00%)  4 2/24 (8.33%)  2 2/21 (9.52%)  3
Headache * 1  1/10 (10.00%)  6 0/24 (0.00%)  0 4/21 (19.05%)  7
Tremor * 1  0/10 (0.00%)  0 2/24 (8.33%)  2 2/21 (9.52%)  2
Convulsion * 1  0/10 (0.00%)  0 1/24 (4.17%)  1 2/21 (9.52%)  2
Dizziness * 1  0/10 (0.00%)  0 1/24 (4.17%)  1 2/21 (9.52%)  2
Respiratory, thoracic and mediastinal disorders       
Cough * 1  1/10 (10.00%)  1 4/24 (16.67%)  4 1/21 (4.76%)  1
Skin and subcutaneous tissue disorders       
Rash * 1  2/10 (20.00%)  2 2/24 (8.33%)  2 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA16.1
*
Indicates events were collected by non-systematic assessment
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
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01969851    
Other Study ID Numbers: SP0966
2012-001446-18 ( EudraCT Number )
First Submitted: October 21, 2013
First Posted: October 25, 2013
Results First Submitted: April 10, 2019
Results First Posted: May 7, 2019
Last Update Posted: May 7, 2019