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A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

NCT00350103 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 551

Last updated 2024-03-22

Study results available
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Summary

The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide.

The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.

Conditions

  • Painful Diabetic Neuropathy

Interventions

DRUG

SPM 929

* Pharmaceutical form: Immediate release film-coated tablets * Concentration: 50mg/ 100mg * Route of administration: Oral use

DRUG

Placebo

* Pharmaceutical form: Immediate release film-coated tablets * Route of administration: Oral use

Sponsors & Collaborators

  • SCHWARZ BIOSCIENCES GmbH - Part of UCB Group

    collaborator UNKNOWN

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCB Cares · 001 844 599 2273 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2007-06-29
Completion
2007-06-29

Countries

  • Germany

Study Locations

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Entities

Drugs

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 NCT00350103 on ClinicalTrials.gov