Trial record 1 of 2 for:
NCT01465997
Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older
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| ClinicalTrials.gov Identifier: NCT01465997 |
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Recruitment Status :
Completed
First Posted : November 6, 2011
Results First Posted : August 2, 2017
Last Update Posted : July 18, 2018
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Sponsor:
UCB BIOSCIENCES GmbH
Collaborator:
Eden Sarl
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES GmbH )
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
| Conditions |
Epilepsy Monotherapy |
| Interventions |
Drug: Lacosamide Drug: Carbamazepine-Controlled Release (CBZ-CR) |
| Enrollment | 551 |
Participant Flow
| Recruitment Details | Enrollment started in May 2012 and concluded in January 2017 - 551 patients. Due to the political and civil unrest in Luhansk PAREXEL was not able to conduct further site visits to one site in Ukraine and to collect further data for 2 subjects,they were excluded from SP0994, leaving 549 patients in the Enrolled Set out of 551 initially enrolled. |
| Pre-assignment Details |
A total of 549 subjects gave informed consent in SP0994 and were included in the Enrolled Set, 548 subjects received at least 1 dose of study medication and were included in the Safety Set (SS). Participant Flow refers to the Safety Population including all enrolled subjects who received at least 1 dose of study medication in the current study. |
| Arm/Group Title | Lacosamide | Carbamazepine-Controlled Release (CBZ-CR) |
|---|---|---|
 Arm/Group Description |
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding. | 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding. |
| Period Title: Overall Study | ||
| Started | 279 | 269 |
| Completed | 211 | 180 |
| Not Completed | 68 | 89 |
| Reason Not Completed | ||
| Adverse Event | 12 | 22 |
| Lack of Efficacy | 13 | 1 |
| Protocol Violation | 1 | 4 |
| Lost to Follow-up | 6 | 9 |
| Withdrawal by Subject | 32 | 35 |
| investigator's decision | 1 | 1 |
| Death | 0 | 1 |
| sponsor's decision | 1 | 1 |
| subject withdrew consent | 1 | 0 |
| local lab unblinded site | 1 | 0 |
| withdrew before follow-up | 0 | 13 |
| decision by site staff | 0 | 1 |
| subject left participation SP0993 | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Lacosamide | Carbamazepine-Controlled Release (CBZ-CR) | Total Title | |
|---|---|---|---|---|
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Arm/Group Description |
50 and 100 mg tablets of Lacosamide given as 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years). CBZ-CR placebo capsules were administered to maintain the blinding. | 200 mg tablets of Carbamazepine-CR given as 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum of 3.5 Years). Lacosamide placebo capsules were administered to maintain the blinding. | [Not Specified] | |
| Overall Number of Baseline Participants | 279 | 269 | 548 | |
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Baseline Analysis Population Description |
The analysis group for Baseline Characteristics is the Safety Set (SS). The SS consists of all subjects in the Enrolled Set who have received 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 | 279 participants | 269 participants | 548 participants | |
| <=18 years |
8 2.9%
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8 3.0%
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16 2.9%
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| Between 18 and 65 years |
230 82.4%
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225 83.6%
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455 83.0%
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| >=65 years |
41 14.7%
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36 13.4%
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77 14.1%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 279 participants | 269 participants | 548 participants | |
| 43.2 (17.2) | 42.7 (16.7) | 42.9 (17.0) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 279 participants | 269 participants | 548 participants | |
| Female |
125 44.8%
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125 46.5%
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250 45.6%
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| Male |
154 55.2%
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144 53.5%
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298 54.4%
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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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | UCB Pharma ( UCB BIOSCIENCES GmbH ) |
| ClinicalTrials.gov Identifier: | NCT01465997 |
| Other Study ID Numbers: |
SP0994 2010-021238-74 ( EudraCT Number ) |
| First Submitted: | November 2, 2011 |
| First Posted: | November 6, 2011 |
| Results First Submitted: | June 27, 2017 |
| Results First Posted: | August 2, 2017 |
| Last Update Posted: | July 18, 2018 |