Trial record 1 of 1 for:
NCT00237458
An Open-label Continuation Trial to Assess the Continued Efficacy and Safety of Ascending Doses of Lacosamide in Subjects With Chronic Refractory Neuropathic Pain
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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: NCT00237458 |
Recruitment Status :
Completed
First Posted : October 12, 2005
Results First Posted : May 15, 2012
Last Update Posted : August 28, 2017
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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: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Chronic Refractory Neuropathic Pain |
Intervention |
Drug: Lacosamide |
Enrollment | 7 |
Participant Flow
Recruitment Details | The study started in May 2001 with subjects from Germany. The primary completion date and study completion date occurred in March 2011. |
Pre-assignment Details | One subject was discontinued on the study due to the Adverse Event of Vertigo. However, the Termination page of the Case Report Form reflected that the subject withdrew consent. Therefore, the Participant Flow will reflect 3 subjects did not complete the study, while the subjects withdrawing from Adverse Events will reflect 2. |
Arm/Group Title | Lacosamide |
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Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years |
Period Title: Overall Study | |
Started | 7 |
Completed | 4 |
Not Completed | 3 |
Reason Not Completed | |
Lack of Efficacy | 1 |
Adverse Event | 1 |
Withdrawal by Subject | 1 |
Baseline Characteristics
Arm/Group Title | Lacosamide | |
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Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years | |
Overall Number of Baseline Participants | 7 | |
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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 | 7 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
7 100.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 7 participants | |
47.4 (10.18) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 7 participants | |
Female |
4 57.1%
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Male |
3 42.9%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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Germany | Number Analyzed | 7 participants |
7 |
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 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 the results shall be published regardless of outcome.
Results Point of Contact
Name/Title: | UCB (Study Director) |
Organization: | UCB Clinical Trial Call Center |
Phone: | +1 887 822 9493 |
Publications of Results:
Responsible Party: | UCB Pharma |
ClinicalTrials.gov Identifier: | NCT00237458 |
Other Study ID Numbers: |
SP0647 |
First Submitted: | October 11, 2005 |
First Posted: | October 12, 2005 |
Results First Submitted: | March 7, 2012 |
Results First Posted: | May 15, 2012 |
Last Update Posted: | August 28, 2017 |