Trial record 1 of 1 for:
NCT01921205
Study to Investigate Lacosamide as Add-on Therapy in Subjects ≥4 Years to <17 Years of Age With Partial Onset Seizures
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ClinicalTrials.gov Identifier: NCT01921205 |
Recruitment Status :
Completed
First Posted : August 13, 2013
Results First Posted : March 19, 2018
Last Update Posted : July 18, 2018
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Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Epilepsy |
Interventions |
Drug: Lacosamide Other: Placebo |
Enrollment | 404 |
Participant Flow
Recruitment Details | The study started to enroll patients in August 2013 and concluded in January 2017. |
Pre-assignment Details | The Participant Flow refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication. |
Arm/Group Title | Placebo | Lacosamide |
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This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets. | This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study. |
Period Title: Overall Study | ||
Started | 172 | 171 |
Completed | 151 | 151 |
Not Completed | 21 | 20 |
Reason Not Completed | ||
Adverse Event | 12 | 7 |
Lack of Efficacy | 1 | 0 |
Protocol Violation | 1 | 3 |
Lost to Follow-up | 1 | 1 |
Withdrawal by Subject | 6 | 5 |
Use Of Prohibited Medication | 0 | 1 |
The Excessive Use Of Rescue Medication | 0 | 1 |
Non Compliance Of The Parent | 0 | 1 |
Non Compliance Of Child | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Placebo | Lacosamide | Total Title | |
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This arm includes subjects with epilepsy, who received a flexible dose of Placebo oral solution or tablets, administered twice a day. Appearance of Placebo oral solution and tablets matched the Lacosamide oral solution and tablets. | This arm includes subjects with epilepsy, who received a flexible dose of Lacosamide (LCM) oral solution or tablets, administered twice a day. Subjects weighing <30kg received 8mg/kg/day to 12mg/kg/day Lacosamide (LCM) oral solution; subjects weighing >=30kg to <50kg received 6mg/kg/day to 8mg/kg/day LCM oral solution; and subjects weighing >=50kg received 300mg/day to 400mg/day LCM tablets, or if unable or unwilling to swallow tablets may have received LCM oral solution, however, they were not permitted to exceed the maximum dose of LCM 400mg/day. The subject's body weight at Baseline (Visit 2) was used to determine the dose throughout the study. | [Not Specified] | |
Overall Number of Baseline Participants | 172 | 171 | 343 | |
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The Baseline Characteristics refers to the Safety Set which included all randomized subjects who took at least 1 dose of study medication.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 172 participants | 171 participants | 343 participants | |
<=18 years |
172 100.0%
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171 100.0%
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343 100.0%
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Between 18 and 65 years |
0 0.0%
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0 0.0%
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0 0.0%
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>=65 years |
0 0.0%
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0 0.0%
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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 172 participants | 171 participants | 343 participants | |
10.9 (3.5) | 10.5 (3.6) | 10.7 (3.5) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 172 participants | 171 participants | 343 participants | |
Female |
73 42.4%
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80 46.8%
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153 44.6%
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Male |
99 57.6%
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91 53.2%
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190 55.4%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 172 participants | 171 participants | 343 participants | |
American Indian or Alaska Native |
1 0.6%
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0 0.0%
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1 0.3%
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Asian |
35 20.3%
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25 14.6%
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60 17.5%
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Black or African American |
1 0.6%
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2 1.2%
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3 0.9%
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White |
129 75.0%
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138 80.7%
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267 77.8%
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Other/Mixed |
6 3.5%
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6 3.5%
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12 3.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844 599 ext 2273 |
EMail: | UCBCares@ucb.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT01921205 |
Other Study ID Numbers: |
SP0969 2012-004996-38 ( EudraCT Number ) |
First Submitted: | August 8, 2013 |
First Posted: | August 13, 2013 |
Results First Submitted: | January 23, 2018 |
Results First Posted: | March 19, 2018 |
Last Update Posted: | July 18, 2018 |