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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

551 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-06-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Painful Diabetic Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lacosamide Standard Titration (ST)

Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.

Group Type EXPERIMENTAL

SPM 929

Intervention Type DRUG

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

Lacosamide Fast Titration (FT)

Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.

Group Type EXPERIMENTAL

SPM 929

Intervention Type DRUG

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

Placebo

Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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SPM 929

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Lacosamide

Eligibility Criteria

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Inclusion Criteria

* Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).

Exclusion Criteria

* Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No