A Follow-On Trial to Assess the Long Term Safety and Efficacy of SPM 927 in Painful Distal Diabetic Neuropathy

June 20, 2018 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Phase 2
  • Phase 3

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States
      • Hoover, Alabama, United States
      • Huntsville, Alabama, United States
      • Northport, Alabama, United States
      • Tuscaloosa, Alabama, United States
    • Arizona
      • Peoria, Arizona, United States
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Hot Springs, Arkansas, United States
      • Jonesboro, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Irvine, California, United States
      • Los Angeles, California, United States
      • San Diego, California, United States
      • Santa Monica, California, United States
      • Spring Valley, California, United States
      • Tustin, California, United States
      • Walnut Creek, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Stratford, Connecticut, United States
    • Delaware
      • Newark, Delaware, United States
      • Wilmington, Delaware, United States
    • Florida
      • Bradenton, Florida, United States
      • Clearwater, Florida, United States
      • Fort Myers, Florida, United States
      • New Port Richey, Florida, United States
      • Ocala, Florida, United States
      • Pembroke Pines, Florida, United States
      • Pinellas Park, Florida, United States
      • Saint Petersburg, Florida, United States
      • South Miami, Florida, United States
      • Sunrise, Florida, United States
      • Tallahassee, Florida, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
      • Elk Grove Village, Illinois, United States
      • North Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Iowa
      • West Des Moines, Iowa, United States
    • Kentucky
      • Crestview Hills, Kentucky, United States
      • Louisville, Kentucky, United States
      • Madisonville, Kentucky, United States
      • Paducah, Kentucky, United States
    • Maryland
      • Owings Mills, Maryland, United States
      • Towson, Maryland, United States
    • Massachusetts
      • Brockton, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
    • Missouri
      • Saint Louis, Missouri, United States
    • Montana
      • Great Falls, Montana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Lawrenceville, New Jersey, United States
      • Voorhees, New Jersey, United States
    • New York
      • Albany, New York, United States
      • Mineola, New York, United States
      • White Plains, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • Greensboro, North Carolina, United States
      • Greenville, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Upland, Pennsylvania, United States
    • South Carolina
      • Greer, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Amarillo, Texas, United States
      • Dallas, Texas, United States
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
      • Richardson, Texas, United States
      • San Antonio, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Virginia
      • Richmond, Virginia, United States
      • Salem, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Washington
      • Spokane, Washington, United States
      • Tacoma, Washington, United States
      • Wenatchee, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Drug: lacosamide
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.
Other Names:
  • SPM927

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Time Frame: Throughout the study up to a maximum study period of 2.8 years
Number of subjects with adverse events (AEs) reported spontaneously by the subject or observed by the investigator (serious and non-serious).
Throughout the study up to a maximum study period of 2.8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Time Frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
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.
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Change From Baseline in Average Pain Score as Measured by a 100mm Visual Analogue Scale (VAS).
Time Frame: Baseline to end of entire treatment phase (maximum study period of 2.8 years).
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.
Baseline to end of entire treatment phase (maximum study period of 2.8 years).
Patient's Global Impression of Change (PGIC) From Baseline in Pain.
Time Frame: Baseline to Termination Visit
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).
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Intensity.
Time Frame: Baseline to Termination Visit
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.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sharpness
Time Frame: Baseline to Termination Visit
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").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Heat
Time Frame: Baseline to Termination Visit
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").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Dullness
Time Frame: Baseline to Termination Visit
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.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Cold
Time Frame: Baseline to Termination Visit
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").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Sensitivity
Time Frame: Baseline to Termination Visit
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").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Itchiness
Time Frame: Baseline to Termination Visit
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").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Unpleasantness
Time Frame: Baseline to Termination Visit
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").
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Deep Pain
Time Frame: Baseline to Termination Visit
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.
Baseline to Termination Visit
Within-subject Change in Neuropathic Pain Using the Neuropathic Pain Scale (NPS) - Surface Pain
Time Frame: Baseline to Termination Visit
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.
Baseline to Termination Visit
Change From Baseline in Average Pain Interference With Sleep (11-point Likert Scale)
Time Frame: Baseline to end of entire treatment phase visit
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.
Baseline to end of entire treatment phase visit
Change From Baseline in Average Pain Interference With Activity (11-point Likert Scale)
Time Frame: Baseline to end of entire treatment phase visit
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.
Baseline to end of entire treatment phase visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Physical Component Summary (PCS)
Time Frame: Baseline to Termination Visit
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.
Baseline to Termination Visit
Change From Baseline in Quality of Life Using the SF-36 Health Survey - Mental Component Summary (MCS)
Time Frame: Baseline to Termination Visit
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.
Baseline to Termination Visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 6, 2005

First Submitted That Met QC Criteria

October 6, 2005

First Posted (Estimate)

October 10, 2005

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

June 20, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP0745

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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