Trial record 1 of 2 for:
NCT00655551
Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
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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: NCT00655551 |
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Recruitment Status :
Completed
First Posted : April 10, 2008
Results First Posted : October 20, 2010
Last Update Posted : July 17, 2018
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Sponsor:
UCB BIOSCIENCES, Inc.
Information provided by (Responsible Party):
UCB Pharma ( UCB BIOSCIENCES, Inc. )
- Study Details
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- How to Read a Study Record
| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
| Conditions |
Partial Epilepsies Partial Onset Seizures |
| Intervention |
Drug: lacosamide |
| Enrollment | 100 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Lacosamide (200 mg) | Lacosamide (300 mg) | Lacosamide (400 mg) |
|---|---|---|---|
 Arm/Group Description |
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily | Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily | Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily |
| Period Title: All Periods Combined | |||
| Started | 25 | 50 | 25 |
| Completed | 25 | 47 | 21 |
| Not Completed | 0 | 3 | 4 |
| Reason Not Completed | |||
| Adverse Event | 0 | 3 | 4 |
| Period Title: Period 1 (up to 7 Days) | |||
| Started | 25 | 0 | 0 |
| Completed | 25 | 0 | 0 |
| Not Completed | 0 | 0 | 0 |
| Period Title: Period 2 (up to 7 Days) | |||
| Started | 0 | 25 | 0 |
| Completed | 0 | 24 | 0 |
| Not Completed | 0 | 1 | 0 |
| Reason Not Completed | |||
| Adverse Event | 0 | 1 | 0 |
| Period Title: Period 3 (up to 7 Days) | |||
| Started | 0 | 0 | 25 |
| Completed | 0 | 0 | 21 |
| Not Completed | 0 | 0 | 4 |
| Reason Not Completed | |||
| Adverse Event | 0 | 0 | 4 |
| Period Title: Period 4 (up to 7 Days) | |||
| Started | 0 | 25 | 0 |
| Completed | 0 | 23 | 0 |
| Not Completed | 0 | 2 | 0 |
| Reason Not Completed | |||
| Adverse Event | 0 | 2 | 0 |
Baseline Characteristics
| Arm/Group Title | Lacosamide (200 mg) | Lacosamide (300 mg) | Lacosamide (400 mg) | Total | |
|---|---|---|---|---|---|
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Arm/Group Description |
Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily | Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily | Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily | Total of all reporting groups | |
| Overall Number of Baseline Participants | 25 | 50 | 25 | 100 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 50 participants | 25 participants | 100 participants | |
| <=18 years |
0 0.0%
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2 4.0%
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0 0.0%
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2 2.0%
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| Between 18 and 65 years |
25 100.0%
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48 96.0%
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25 100.0%
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98 98.0%
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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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0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 25 participants | 50 participants | 25 participants | 100 participants | |
| 39.1 (11.77) | 38.6 (11.53) | 39.6 (12.24) | 39.0 (11.66) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 25 participants | 50 participants | 25 participants | 100 participants | |
| Female |
14 56.0%
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26 52.0%
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9 36.0%
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49 49.0%
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| Male |
11 44.0%
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24 48.0%
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16 64.0%
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51 51.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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| United States | Number Analyzed | 25 participants | 50 participants | 25 participants | 100 participants |
| 25 | 50 | 25 | 100 | ||
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
| Name/Title: | UCB Clinical Trial Call Center |
| Organization: | UCB, Inc |
| Phone: | +1 877 822 9493 |
| Responsible Party: | UCB Pharma ( UCB BIOSCIENCES, Inc. ) |
| ClinicalTrials.gov Identifier: | NCT00655551 |
| Other Study ID Numbers: |
SP0925 2014-004378-40 ( EudraCT Number ) |
| First Submitted: | March 26, 2008 |
| First Posted: | April 10, 2008 |
| Results First Submitted: | September 23, 2010 |
| Results First Posted: | October 20, 2010 |
| Last Update Posted: | July 17, 2018 |