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Study Evaluating Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Distal Diabetic Neuropathy.

NCT00546351 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2023-09-21

Study results available
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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.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

Lacosamide

50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00546351 on ClinicalTrials.gov