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

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ClinicalTrials.gov Identifier: NCT00238524
Recruitment Status : Completed
First Posted : October 13, 2005
Last Update Posted : September 22, 2014
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: SPM 927 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 357 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : December 2003
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00238524


Locations
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Germany
Schwarz
Monheim, Germany
Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information
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Additional Information:

Publications of Results:

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ClinicalTrials.gov Identifier: NCT00238524    
Other Study ID Numbers: SP0743
First Posted: October 13, 2005    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: April 2010
Keywords provided by UCB Pharma:
painful distal diabetic neuropathy
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
 Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases