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Trial record 7 of 519 for:    Diabetic Neuropathy
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A Trial to Assess the Efficacy and Safety of SPM 927 (Lacosamide) in Subjects With Painful Distal Diabetic Neuropathy

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00238524
First received: October 11, 2005
Last updated: April 8, 2010
Last verified: April 2010
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Lacosamide
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00238524     History of Changes
Other Study ID Numbers: SP743
Study First Received: October 11, 2005
Last Updated: April 8, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by UCB, Inc.:
painful distal diabetic neuropathy

Additional relevant MeSH terms:
Diabetic Neuropathies
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Peripheral Nervous System Diseases
Neuromuscular Diseases
 Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on May 23, 2013