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A Trial to Assess the Long-term Safety and Efficacy of Lacosamide in Subjects With Painful Diabetic Neuropathy

NCT00220337 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 371

Last updated 2023-07-24

Study results available
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Summary

The purpose of this study is to determine if lacosamide (SPM 927) is safe if taken for a longer period of time and whether it continues to work well to treat pain.

Subjects will receive lacosamide at a dose that will be individually determined to be the one that provides most pain relief with the least side effects. The maximum dose will be 600mg/day. Subjects may participate in this trial until October 2007. This time may be extended to allow them to participate until lacosamide is commercially available.

If a subject meet the requirements for the study at Visit 1 and after a two weeks phase without trial medication, s/he enters a Titration Phase to determine the personal optimal dose of lacosamide. When this dose is reached s/he will enter the Maintenance Phase and will be asked to return for visits every 4 weeks for the first 24 weeks and every 12 weeks thereafter.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

Lacosamide

Lacosamide film-coated tablets; two times per day; up to 400 mg/day for 2.75 years

Sponsors & Collaborators

  • SCHWARZ BIOSCIENCES GmbH - Part of UCB Group

    collaborator UNKNOWN

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Cares · UCB (+1 844 599 2273)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-21
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Germany

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 NCT00220337 on ClinicalTrials.gov