Trial record 1 of 1 for:
NCT00440518
A Study Designed to Test the Effectiveness and Safety of Treating Patients With Lacosamide for Migraine Prophylaxis (SP906)
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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: NCT00440518 |
Recruitment Status :
Completed
First Posted : February 27, 2007
Results First Posted : September 11, 2009
Last Update Posted : July 17, 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: Prevention |
Condition |
Migraine |
Interventions |
Drug: Lacosamide Other: Placebo |
Enrollment | 218 |
Participant Flow
Recruitment Details | A multicenter trial with 24 sites with enrolled subjects and 23 sites with randomized subjects from 15 Feb 2007 to 17 Jul 2008. |
Pre-assignment Details | Subjects on stable dose of prophylactic medication entered a 2-week Wash-Out Period followed by a 4-week Baseline Period without any prophylactic medication. Subjects not taking prophylactic medication entered the Baseline Period directly for 6 weeks. Subjects entered a 3-week Titration Period and if completed entered a 14-week Maintenance Period. |
Arm/Group Title | Placebo | Lacosamide 100mg | Lacosamide 300mg |
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Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart | Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart | Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart |
Period Title: Randomized /Titration Period | |||
Started | 72 | 72 | 74 |
Completed | 59 | 63 | 70 |
Not Completed | 13 | 9 | 4 |
Reason Not Completed | |||
Lack of Efficacy | 1 | 0 | 1 |
Subject Withdrew Consent | 4 | 1 | 0 |
Protocol Deviation | 1 | 0 | 0 |
Unsatisfactory Compliance | 2 | 3 | 2 |
Other | 1 | 0 | 0 |
Lost to Follow-up | 2 | 2 | 1 |
Adverse Event | 2 | 3 | 0 |
Period Title: Maintenance and Safety Follow-up Periods | |||
Started | 59 | 63 | 70 |
Completed | 52 | 51 | 55 |
Not Completed | 7 | 12 | 15 |
Reason Not Completed | |||
Adverse Event | 3 | 4 | 2 |
Lack of Efficacy | 0 | 1 | 1 |
Subject Withdrew Consent | 3 | 2 | 4 |
Unsatisfactory Compliance | 0 | 3 | 6 |
Other | 0 | 0 | 2 |
Lost to Follow-up | 1 | 2 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | Lacosamide 100mg | Lacosamide 300mg | Total | |
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Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart | Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart | Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart | Total of all reporting groups | |
Overall Number of Baseline Participants | 72 | 72 | 74 | 218 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 72 participants | 72 participants | 74 participants | 218 participants | |
<=18 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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Between 18 and 65 years |
72 100.0%
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72 100.0%
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74 100.0%
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218 100.0%
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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 | 72 participants | 72 participants | 74 participants | 218 participants | |
39.3 (12.23) | 40.1 (11.86) | 40.2 (11.40) | 39.9 (11.78) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 72 participants | 72 participants | 74 participants | 218 participants | |
Female |
62 86.1%
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62 86.1%
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63 85.1%
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187 85.8%
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Male |
10 13.9%
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10 13.9%
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11 14.9%
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31 14.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 72 participants | 72 participants | 74 participants | 218 participants |
72 | 72 | 74 | 218 |
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 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: | Study Director |
Organization: | UCB Clinical Trial Call Center |
Phone: | +1 877 822 9493 |
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00440518 |
Other Study ID Numbers: |
SP0906 |
First Submitted: | February 23, 2007 |
First Posted: | February 27, 2007 |
Results First Submitted: | August 3, 2009 |
Results First Posted: | September 11, 2009 |
Last Update Posted: | July 17, 2018 |