Trial record 1 of 1 for:
NCT00485472
Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee
|
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: NCT00485472 |
|
Recruitment Status :
Terminated
(Based on the outcome of the planned first interim analysis, it was decided not to continue the trial. No safety concerns were identified.)
First Posted : June 13, 2007
Results First Posted : September 22, 2009
Last Update Posted : August 28, 2017
|
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 |
Osteoarthritis |
| Interventions |
Drug: lacosamide Other: Placebo |
| Enrollment | 194 |
Participant Flow
| Recruitment Details | Trial utilized an adaptive 3-stage group sequential design. The Data Monitoring Committee had recommended to stop the trial after the first stage due to lack of efficacy. Results refer to the entire population randomized until discontinuation of study (including overrun). |
| Pre-assignment Details | Of the 194 enrolled subjects, 149 subjects have been randomized until trial termination. The Participants flow refers to the randomized population. Of the 149 randomized subjects, 148 subjects have been treated and are included in the safety population, 145 have been included in the ITT population (Full Analysis Set). |
| Arm/Group Title | Lacosamide | Placebo |
|---|---|---|
 Arm/Group Description |
Lacosamide (LCM) 400 mg/day | Placebo |
| Period Title: Overall Study | ||
| Started | 73 | 76 |
| Entered Maintenance Phase | 65 | 67 |
| Completed | 57 | 64 |
| Not Completed | 16 | 12 |
| Reason Not Completed | ||
| Adverse Event | 8 | 5 |
| Lack of Efficacy | 5 | 4 |
| Withdrawal by Subject | 1 | 0 |
| Protocol Violation | 0 | 1 |
| Other | 2 | 1 |
| Lost to Follow-up | 0 | 1 |
Baseline Characteristics
| Arm/Group Title | Lacosamide | Placebo | Total | |
|---|---|---|---|---|
|
Arm/Group Description |
Lacosamide (LCM) 400 mg/day | Placebo | Total of all reporting groups | |
| Overall Number of Baseline Participants | 73 | 76 | 149 | |
|
Baseline Analysis Population Description |
[Not Specified]
|
|||
|
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 73 participants | 76 participants | 149 participants | |
| <=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
| Between 18 and 65 years |
40 54.8%
|
46 60.5%
|
86 57.7%
|
|
| >=65 years |
33 45.2%
|
30 39.5%
|
63 42.3%
|
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
| Number Analyzed | 73 participants | 76 participants | 149 participants | |
| 61.0 (8.03) | 62.3 (6.74) | 61.7 (7.40) | ||
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
| Number Analyzed | 73 participants | 76 participants | 149 participants | |
| Female |
52 71.2%
|
59 77.6%
|
111 74.5%
|
|
| Male |
21 28.8%
|
17 22.4%
|
38 25.5%
|
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 73 participants | 76 participants | 149 participants |
| Hungary | 20 | 22 | 42 | |
| Czech Republic | 8 | 10 | 18 | |
| Germany | 27 | 27 | 54 | |
| Poland | 9 | 9 | 18 | |
| Romania | 9 | 8 | 17 | |
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: | UCB Clinical Trial Call Center |
| Organization: | UCB Pharma |
| Phone: | +1 877 822 9493 |
| Responsible Party: | UCB Pharma |
| ClinicalTrials.gov Identifier: | NCT00485472 |
| Other Study ID Numbers: |
SP0905 2006-005048-97 ( EudraCT Number ) |
| First Submitted: | June 12, 2007 |
| First Posted: | June 13, 2007 |
| Results First Submitted: | August 12, 2009 |
| Results First Posted: | September 22, 2009 |
| Last Update Posted: | August 28, 2017 |