Assessing Efficacy and Safety of Lacosamide Compared to Placebo in Reducing Signs and Symptoms of Fibromyalgia Syndrome.
![]() |
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: NCT00401830 |
Recruitment Status :
Completed
First Posted : November 22, 2006
Results First Posted : October 22, 2009
Last Update Posted : July 18, 2018
|
Sponsor:
UCB Pharma
Information provided by (Responsible Party):
UCB Pharma
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment |
Condition |
Fibromyalgia Syndrome |
Interventions |
Drug: Lacosamide Other: Placebo |
Enrollment | 159 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | Lacosamide |
---|---|---|
![]() |
Matching placebo tablet (administered twice daily) | Lacosamide Tablet 400mg daily (administered twice daily) |
Period Title: Overall Study | ||
Started | 81 | 78 |
Completed | 50 | 46 |
Not Completed | 31 | 32 |
Reason Not Completed | ||
Adverse Event | 10 | 18 |
Lack of Efficacy | 11 | 5 |
Withdrawal by Subject | 4 | 3 |
Protocol Violation | 3 | 3 |
Non-compliance with drug study | 1 | 0 |
Lost to Follow-up | 1 | 3 |
Other: Personal / Family problems | 1 | 0 |
Baseline Characteristics
Arm/Group Title | Placebo | Lacosamide | Total | |
---|---|---|---|---|
![]() |
Matching placebo tablet (administered twice daily) | Lacosamide Tablet 400mg daily (administered twice daily) | Total of all reporting groups | |
Overall Number of Baseline Participants | 81 | 78 | 159 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 81 participants | 78 participants | 159 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
79 97.5%
|
76 97.4%
|
155 97.5%
|
|
>=65 years |
2 2.5%
|
2 2.6%
|
4 2.5%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 81 participants | 78 participants | 159 participants | |
50.4 (10.5) | 48.9 (11.1) | 49.7 (10.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 81 participants | 78 participants | 159 participants | |
Female |
77 95.1%
|
71 91.0%
|
148 93.1%
|
|
Male |
4 4.9%
|
7 9.0%
|
11 6.9%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 81 participants | 78 participants | 159 participants |
81 | 78 | 159 |
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: | NCT00401830 |
Other Study ID Numbers: |
SP0887 |
First Submitted: | November 9, 2006 |
First Posted: | November 22, 2006 |
Results First Submitted: | September 22, 2009 |
Results First Posted: | October 22, 2009 |
Last Update Posted: | July 18, 2018 |