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

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00238524

Purpose

This trial was conducted at about 50 sites in Europe and has been clinically completed. Patients had symptoms of painful diabetic neuropathy for 6 months up to 5 years with an optimized diabetic control and at least moderate pain. Patients were not eligible with other chronic pain or any other medical or psychiatric condition, that would have jeopardized or compromised the patient's ability to participate in the trial. After a 2-week run-in phase patients were randomly assigned to one of three treatment arms. All patients who had completed the 6-week titration phase to reach their target dose entered a 12-week maintenance phase. At the end of the maintenance phase, subjects were offered the option of entering the open-label, follow-on trial. The change in pain was measured daily as well as interference of pain with sleep and general activity.

Condition	Intervention	Phase
Diabetic Neuropathy	Drug: SPM 927	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, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of 400mg/Day and 600mg/Day SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

Further study details as provided by UCB:

Primary Outcome Measures:

Investigate the efficacy of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy will be determined by pain score ratings assessed in a patient's diary and at clinic visits.

Secondary Outcome Measures:

Investigate effect of lacosmide on subjects' perception of sleep, activity, quality of life, and safety, determined by rating scales assessed in a patient's diary and at the clinic visits.

Enrollment:	357
Study Start Date:	December 2003
Study Completion Date:	January 2005
Primary Completion Date:	January 2005 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Painful distal diabetic neuropathy

Exclusion Criteria:

Symptoms of painful distal diabetic neuropathy for less than six months or greater than 5 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238524

Locations

Germany
Schwarz
Monheim, Germany

Sponsors and Collaborators

UCB

Investigators

Study Director:

Sabine Bongardt

Schwarz

More Information

Study ID Numbers:	SP743
Study First Received:	October 11, 2005
Last Updated:	March 7, 2008
ClinicalTrials.gov Identifier:	NCT00238524
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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 14, 2009