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

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ClinicalTrials.gov Identifier: NCT00235469
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : September 22, 2014
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Diabetic Neuropathy Drug: SPM 927 Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 496 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : April 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00235469


Locations
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United States, North Carolina
Schwarz
RTP, North Carolina, United States
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: NCT00235469    
Other Study ID Numbers: SP0742
First Posted: October 10, 2005    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: February 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