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Trial to Assess the Efficacy and Safety of SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy

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ClinicalTrials.gov Identifier: NCT00135109
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : September 22, 2014
Sponsor:
Information provided by:

Study Description
Brief Summary:

This phase 3 trial is being conducted at approximately 80 sites in the United States (U.S.) to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 455 subjects will be randomized to placebo or to 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 greater than or equal to 4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to the 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; and pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, the safety and tolerability of the different doses of lacosamide will be investigated.


Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: SPM 927 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 654 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 SPM 927 (200, 400, and 600mg/Day) in Subjects With Painful Distal Diabetic Neuropathy
Study Start Date : October 2004
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To investigate the efficacy of 200, 400, and 600mg/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, and quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic neuropathy

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.
Contacts and Locations

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): NCT00135109


Locations
United States, North Carolina
Schwarz
RTP, North Carolina, United States, 27709
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00135109     History of Changes
Other Study ID Numbers: SP0768
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: September 22, 2014
Last Verified: February 2010

Additional relevant MeSH terms:
Diabetic Neuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases