Back to resultsA Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Primary Purpose
Diabetic Neuropathy
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lacosamide
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Painful Distal Diabetic Neuropathy
Eligibility Criteria
Inclusion Criteria: Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor. Exclusion Criteria: Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768. Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN. Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Outcomes
Primary Outcome Measures
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Secondary Outcome Measures
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00235443
Brief Title
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
Official Title
A Multi-Center, Open-Label, Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Phase 2/3 open-label trial to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. The safety and tolerability of the different doses of lacosamide will be investigated.
Detailed Description
This phase 2/3 open-label trial is being conducted at approximately 100 sites in the US to assess the safety and tolerability of long-term treatment with lacosamide (SPM 927) in subjects with painful diabetic neuropathy. Approximately 525 subjects will be enrolled. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have completed trials SP665, SP742, or SP768 and, in the investigator's opinion, may benefit from long-term administration of lacosamide. Subjects will be titrated to their optimal dose of lacosamide (up to 600mg/day). The safety and tolerability of the different doses of lacosamide will be investigated throughout the trial. In addition, to determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity and pain interference with sleep and activity. Subjects' quality of life will also be investigated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Painful Distal Diabetic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
451 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Intervention Type
Drug
Intervention Name(s)
lacosamide
Other Intervention Name(s)
SPM927
Intervention Description
Open-label treatment (two times per day) with film-coated tablets include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, and 600mg/day throughout individual study period.
Primary Outcome Measure Information:
Title
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Description
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Time Frame
Throughout the study up to a maximum study period of 2.8 years
Secondary Outcome Measure Information:
Title
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Description
Change from Baseline in average daily pain score using an 11-point Likert scale (0-10). On Likert scale, 0=no pain and 10=worst possible pain.
Time Frame
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Title
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Description
Change from Baseline in average pain score as measured by a 100mm Visual Analogue Scale (VAS). On VAS 0mm=no pain and 100mm=worst possible pain.
Time Frame
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Title
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Description
Patient's Global Impression of Change (PGIC) from Baseline in Pain. Original categorical responses are much worse, moderately worse, mildly worst, no change, mildly better, moderately better, and much better. Reported results are presented as Better (sum of mildly, moderately, or much better), No Change, or Worse (sum of mildly, moderately, or much worse).
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for intensity of pain where 0=no pain and 10=most intense pain sensation imaginable.
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) for sharpness of pain where 0=not sharp and 10=most sharp sensation imaginable ("like a knife").
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with heat sensation where 0=not hot and 10=the most hot sensation imaginable ("on fire").
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with dullness of pain where 0=not dull and 10=most dull sensation imaginable.
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with cold sensation where 0=not cold and 10=most cold sensation imaginable ("freezing").
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with sensitivity of pain where 0=not sensitive and 10=most sensitive sensation imaginable ("raw skin").
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with itchiness where 0=not itchy and 10=most itchy sensation imaginable ("like poison oak").
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with unpleasantness where 0=not pleasant and 10=most unpleasant sensation imaginable ("intolerable").
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with deep pain where 0=no deep pain and 10=most intense deep pain sensation imaginable.
Time Frame
Baseline to Termination Visit
Title
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Description
Within-subject change in neuropathic pain using the Neuropathic Pain Scale (NPS) with surface pain where 0=no surface pain and 10=most intense surface pain imaginable.
Time Frame
Baseline to Termination Visit
Title
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Description
Change from Baseline in average pain interference with sleep (11-point Likert scale) where 0=no interference with sleep and 10=worst possible interference with sleep.
Time Frame
Baseline to end of entire treatment phase visit
Title
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Description
Change from Baseline in average pain interference with activity (11-point Likert scale) where 0=no interfence with activity and 10=worst possible interference with activity.
Time Frame
Baseline to end of entire treatment phase visit
Title
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Description
Change from Baseline in quality of life using the SF-36 Health Survey - Physical Component Summary (PCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Time Frame
Baseline to Termination Visit
Title
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Description
Change from Baseline in quality of life using the SF-36 Health Survey - Mental Component Summary (MCS). Values range from 0 to 100 with high values indicating a good condition. Positive change in baseline values indicate improvement in quality of life.
Time Frame
Baseline to Termination Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
32 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who completed Study SP665, SP742, or SP768 and, in the investigators opinion, might benefit from long-term administration of SPM 927. Exception: subjects who prematurely discontinued Study SP742 or SP768 due to lack of efficacy or due to intolerability to trial medication may be eligible to participate in Study SP745, after consultation with the medical monitor.
Exclusion Criteria:
Subject has clinically relevant electrocardiogram (ECG) abnormalities, or QT-corrected (QTc) interval >=500 milliseconds (ms), and/or a QTc interval increase of >=60ms from the mean pre-dose QTc value at Visit 2 of Studies SP665, SP742 or SP768.
Subject has aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >=3 times the upper limit of the normal range (ULN) with total bilirubin >=2 times ULN or transaminases (AST and/or ALT) >=5 times ULN.
Subject has a clinically relevant medical condition that, in the opinion of the investigator, jeopardizes or compromises the subject's ability to participate in this trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
Facility Information:
City
Anniston
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Alabama
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United States
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Hoover
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Alabama
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United States
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Huntsville
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Alabama
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Northport
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Tuscaloosa
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Peoria
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Phoenix
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Tucson
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Hot Springs
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Jonesboro
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Little Rock
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Irvine
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Los Angeles
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San Diego
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Santa Monica
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Spring Valley
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Tustin
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Walnut Creek
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Denver
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Colorado
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Stratford
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Connecticut
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Newark
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Delaware
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Wilmington
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Delaware
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Bradenton
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Clearwater
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Fort Myers
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New Port Richey
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Ocala
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Pembroke Pines
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Pinellas Park
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Saint Petersburg
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South Miami
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Sunrise
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Tallahassee
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Marietta
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Georgia
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Chicago
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Illinois
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Elk Grove Village
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Illinois
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North Chicago
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Evansville
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Indiana
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West Des Moines
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Crestview Hills
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Kentucky
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Louisville
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Madisonville
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Paducah
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Owings Mills
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Maryland
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Towson
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Brockton
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Massachusetts
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Ann Arbor
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Saint Louis
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Great Falls
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Montana
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Omaha
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Nebraska
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Las Vegas
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Nevada
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Lawrenceville
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New Jersey
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Voorhees
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Albany
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New York
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Mineola
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New York
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White Plains
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New York
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Charlotte
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North Carolina
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Greensboro
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Greenville
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Raleigh
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Winston-Salem
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North Carolina
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Cincinnati
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Ohio
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Toledo
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Ohio
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Oklahoma City
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Oklahoma
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Tulsa
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Oklahoma
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Medford
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Oregon
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Portland
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Oregon
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Upland
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Pennsylvania
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Greer
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South Carolina
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Bristol
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Tennessee
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Nashville
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Tennessee
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Amarillo
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Dallas
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Texas
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Fort Worth
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Texas
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Houston
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Texas
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Richardson
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Texas
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San Antonio
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Texas
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United States
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Bennington
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Vermont
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United States
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Richmond
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Virginia
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United States
City
Salem
State/Province
Virginia
Country
United States
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Virginia Beach
State/Province
Virginia
Country
United States
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Spokane
State/Province
Washington
Country
United States
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Tacoma
State/Province
Washington
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United States
City
Wenatchee
State/Province
Washington
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United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18619874
Citation
Shaibani A, Biton V, Rauck R, Koch B, Simpson J. Long-term oral lacosamide in painful diabetic neuropathy: a two-year open-label extension trial. Eur J Pain. 2009 May;13(5):458-63. doi: 10.1016/j.ejpain.2008.05.016. Epub 2008 Jul 10.
Results Reference
derived
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy
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