A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
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|ClinicalTrials.gov Identifier: NCT00235469|
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : September 22, 2014
This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment.
To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Neuropathy||Drug: SPM 927||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||496 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety OF 200, 400, AND 600 mg/Day SPM 927 in Subjects With Painful Distal Diabetic Neuropathy|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
- To investigate the efficacy of 200, 400, and 600 mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.
- To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.
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): NCT00235469
|United States, North Carolina|
|RTP, North Carolina, United States|
|Study Director:||UCB Clinical Trial Call Center||UCB Pharma|