A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00238524|
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : September 22, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy||Drug: SPM 927||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||357 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||January 2005|
- Investigate the efficacy of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy will be determined by pain score ratings assessed in a patient's diary and at clinic visits.
- Investigate effect of lacosmide on subjects' perception of sleep, activity, quality of life, and safety, determined by rating scales assessed in a patient's diary and at the clinic visits.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00238524
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|