A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy - Full Text View

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00235469

Purpose

This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment.

To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.

Condition	Intervention	Phase
Diabetic Neuropathy	Drug: SPM 927	Phase II Phase III

MedlinePlus related topics: Diabetic Nerve Problems

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial to Assess the Efficacy and Safety OF 200, 400, AND 600 mg/Day SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

Further study details as provided by UCB:

Primary Outcome Measures:

To investigate the efficacy of 200, 400, and 600 mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy.

Secondary Outcome Measures:

To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.

Enrollment:	496
Study Start Date:	April 2004
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Painful distal diabetic neuropathy

Exclusion Criteria:

Must have an average pain intensity of ≥ 4 on an 11-point Likert scale

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235469

Locations

United States, North Carolina
Schwarz
RTP, North Carolina, United States

Sponsors and Collaborators

UCB

Investigators

Study Director:

Jeffrey Simpson

UCB

More Information

Study ID Numbers:	SP742
Study First Received:	October 6, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00235469
Health Authority:	United States: Food and Drug Administration

Keywords provided by UCB:

PAINFUL DISTAL DIABETIC NEUROPATHY

Study placed in the following topic categories:

Neuromuscular Diseases
Diabetic Neuropathies
Peripheral Nervous System Diseases
Diabetes Mellitus

Endocrine System Diseases
Pain
Endocrinopathy
Diabetes Complications

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009