We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00350103
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00350103
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : September 22, 2014
Information provided by:
UCB Pharma

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Painful Diabetic Neuropathy Drug: SPM 929 Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 537 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo Controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy Using Two Different Titration Schemes
Study Start Date : June 2006
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. To investigate the efficacy of LCM compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. Two titration schemes will be used; the first is a standard titration scheme such that the target dose of 400mg/day [ Time Frame: 8 days and 22 days ]

Secondary Outcome Measures :
  1. To investigate the onset of action under treatment of LCM, the effect of LCM on subjects' perception of pain, sleep, activity, and quality of life, and to further investigate the safety of LCM

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350103

Layout table for location information
Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center UCB Pharma
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00350103    
Other Study ID Numbers: SP0874
2005-005788-27 ( EudraCT Number )
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: September 2009
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Neurologic Manifestations
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases