Trial record 1 of 1 for:
NCT00546351
Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.
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ClinicalTrials.gov Identifier: NCT00546351 |
Recruitment Status
:
Completed
First Posted
: October 18, 2007
Results First Posted
: April 19, 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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Tracking Information | ||||
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First Submitted Date ICMJE | October 16, 2007 | |||
First Posted Date ICMJE | October 18, 2007 | |||
Results First Submitted Date | December 21, 2011 | |||
Results First Posted Date | April 19, 2012 | |||
Last Update Posted Date | August 28, 2017 | |||
Study Start Date ICMJE | May 2004 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
To assess the tolerability and safety of long-term lacosamide administration in subjects with painful distal diabetic neuropathy. Assessment of adverse events, changes in laboratory parameters, ECGs, and physical examinations. [ Time Frame: Assessments are made at all clinic visits. ] | |||
Change History | Complete list of historical versions of study NCT00546351 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
The secondary objective is to evaluate the efficacy of long-term use of lacosamide in this indication. Efficacy will be determined by pain score ratings assessed in a patient's diary and with ratings at the clinic visits. [ Time Frame: Efficacy will be determined by pain score ratings assessed in a patient's diary for daily entries and with ratings at the clinic visits. ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy. | |||
Official Title ICMJE | A Multi-center, Open-label, follow-on Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Including a Double-blind, Randomized Time Point Withdrawal Subtrial. | |||
Brief Summary | SP746 (NCT00546351) is a multi-center, open-label, follow-on trial. The purpose of this trial is to assess safety and tolerability of long-term exposure of lacosamide (previously referred to as SPM 927) in subjects with painful distal diabetic neuropathy. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Painful Diabetic Neuropathy | |||
Intervention ICMJE | Drug: Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years
Other Name: Vimpat |
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Study Arms | Experimental: Lacosamide
50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
Intervention: Drug: Lacosamide |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
621 | |||
Original Actual Enrollment ICMJE |
614 | |||
Actual Study Completion Date | January 2011 | |||
Actual Primary Completion Date | January 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Bulgaria, Czechia, Finland, France, Germany, Hungary, Italy, Poland, Romania, Russian Federation, Serbia, Spain, United Kingdom | |||
Removed Location Countries | Czech Republic, Former Serbia and Montenegro | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00546351 | |||
Other Study ID Numbers ICMJE | SP0746 2004-000551-42 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | UCB Pharma | |||
Study Sponsor ICMJE | UCB Pharma | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | UCB Pharma | |||
Verification Date | July 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |