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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2003-02-28

Brief Summary

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

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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

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

SPM927/Lacosamide

Intervention Type DRUG

SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablets two times a day for 10 weeks

Interventions

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SPM927/Lacosamide

SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks

Intervention Type DRUG

Placebo

Placebo tablets two times a day for 10 weeks

Intervention Type OTHER

Other Intervention Names

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SPM927 Lacosamide Vimpat®

Eligibility Criteria

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Inclusion Criteria

* Subject has clinically diagnosed pain attributed to diabetic distal sensory motor polyneuropathy for 1-5 years and a diagnosis of diabetes mellitus (Type I or Type II).
* Subjects must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
* subjects must have good or fair diabetic control (Hgb A1c \< 10%)

Exclusion Criteria

* Subject has other conditions that cause neuropathic pain at least as severe as the diabetic pain i.e. peripheral arterio-vascular disease.
* Subject receives treatment for seizures.
* Subject has had any amputations other than diabetically-related toe amputations.
* Subject has major skin ulcers.
* Subject has clinically significant ECG abnormalities.
* Subject is expected to take within 7 days prior to randomization and during the study: TCAs, mexiletine hydrochloride, lidoderm patch, tramadol, AEDs, dextromethorphan, opioids, capsaicin, nonsteroidal anti-inflammatory drugs, acetaminophen / paracetamol, skeletal muscle relaxants, benzodiazepines, alpha-2-agonists (e.g. clonidine), drugs indicated for sleep disturbance (e. g. zolpidem tartrate, zaleplon) and over-the-counter medications with centrally acting properties.
* Subject has laboratory values which are outside the normal range and judged by the investigator to be clinically significant.
* At study entry, subject has liver function tests values (AST, ALT,alkaline phosphatase, total bilirubin and GGT) 2 times upper limit of normal.
* subject has impaired renal function, i.e., creatinine clearance is lower than 60 mL/min.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No