Clinical Trials Directory

Trials / Completed

CompletedNCT00861445

A Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

A Randomized, Double-Blind Placebo Controlled Trial to Investigate Safety and Efficacy of SPM927 in Painful Diabetic Neuropathy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
119 (actual)
Sponsor
UCB Pharma · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy

Conditions

Interventions

TypeNameDescription
DRUGSPM927/LacosamideSPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
OTHERPlaceboPlacebo tablets two times a day for 10 weeks

Timeline

Start date
2001-06-01
Primary completion
2003-01-01
Completion
2003-02-01
First posted
2009-03-13
Last updated
2014-10-20

Source: ClinicalTrials.gov record NCT00861445. Inclusion in this directory is not an endorsement.