CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 451 enrolled
Drug / intervention
lacosamidedrug
Likely dose
Lacosamide 100–600 mg/day orally (twice daily), dose individually titratedAI-extracted
Key inclusion· 2
  • ✓Completed prior lacosamide study (SP665, SP742, or SP768) and investigator believes subject may benefit from continued treatment
  • ✓Exception: subjects with premature discontinuation from SP742 or SP768 due to lack of efficacy or intolerability may still be eligible after medical monitor consultation
Key exclusion· 4
  • ✕Clinically relevant ECG abnormalities or QTc ≥500 ms
  • ✕QTc interval increase ≥60 ms from baseline (Visit 2 of prior studies)
  • ✕AST and/or ALT ≥3× ULN with total bilirubin ≥2× ULN, or AST/ALT ≥5× ULN
  • ✕Any clinically relevant medical condition that compromises ability to participate in the trial

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00235443
NCT00235443Phase 3Completed
CompareCT.gov

A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

UCB Pharma·interventional·Posted Oct 10, 2005·Updated Jul 17, 2018

In Brief

A Phase 3 clinical trial evaluating lacosamide for Diabetic Neuropathy. Completed, enrolled 451 participants across 84 sites.

Detailed Summary

Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Neuropathy
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 10, 2005
Enrollment StartSep 1, 2004
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 20.7 years ago

Interventions

lacosamidedrug

Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.