A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
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ClinicalTrials.gov Identifier: NCT02582866 |
Recruitment Status :
Completed
First Posted : October 21, 2015
Results First Posted : January 22, 2021
Last Update Posted : August 17, 2021
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Epilepsy |
Intervention |
Drug: Lacosamide |
Enrollment | 106 |
Recruitment Details | The study started to enroll study participants in January 2016 and concluded in January 2020. |
Pre-assignment Details | Participant Flow refers to the Safety Set. |
Arm/Group Title | Lacosamide |
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Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. |
Period Title: Overall Study | |
Started | 106 |
Completed | 84 |
Not Completed | 22 |
Reason Not Completed | |
Death | 1 |
Lack of Efficacy | 2 |
Lost to Follow-up | 2 |
Withdrawal by Subject | 7 |
Investigator decision | 5 |
Participant wants to get pregnant | 1 |
Pregnancy | 2 |
Sponsor decision | 1 |
Withdrawal due to personal reasons | 1 |
Arm/Group Title | Lacosamide | |
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Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. |
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Overall Number of Baseline Participants | 106 | |
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Baseline Characteristics refer to the Safety Set (SS) which consisted of all study participants in the Enrolled Set (ES) who received at least 1 dose of study medication in SP1042.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | |
<=18 years |
2 1.9%
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Between 18 and 65 years |
90 84.9%
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>=65 years |
14 13.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 106 participants | |
43.5 (17.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | |
Female |
48 45.3%
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Male |
58 54.7%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 106 participants | |
Asian |
19 17.9%
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White |
86 81.1%
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Other/Mixed |
1 0.9%
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Name/Title: | UCB |
Organization: | Cares |
Phone: | +1844 599 ext 2273 |
EMail: | UCBCares@ucb.com |
Responsible Party: | UCB Pharma ( UCB Biopharma S.P.R.L. ) |
ClinicalTrials.gov Identifier: | NCT02582866 |
Other Study ID Numbers: |
SP1042 2015-001549-96 ( EudraCT Number ) |
First Submitted: | October 20, 2015 |
First Posted: | October 21, 2015 |
Results First Submitted: | January 4, 2021 |
Results First Posted: | January 22, 2021 |
Last Update Posted: | August 17, 2021 |