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

20. juni 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

451

Fase

  • Fase 2
  • Fase 3

Udvidet adgang

Ikke længere tilgængelig uden for det kliniske forsøg. Se udvidet adgangsregistrering.

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

32 år til 81 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
Medicin: 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.
Andre navne:
  • SPM927

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects With Adverse Events (AEs) Reported Spontaneously by the Subject or Observed by the Investigator.
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Average Daily Pain Score Using an 11-point Likert Scale (0-10).
Tidsramme: 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).
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

UCB Pharma

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2004

Primær færdiggørelse (Faktiske)

1. juli 2008

Studieafslutning (Faktiske)

1. juli 2008

Datoer for studieregistrering

Først indsendt

6. oktober 2005

Først indsendt, der opfyldte QC-kriterier

6. oktober 2005

Først opslået (Skøn)

10. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juni 2018

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SP0745

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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