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Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF Episodes (SPAN-PD™)

23. maj 2019 opdateret af: Acorda Therapeutics

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)

This randomized, multicenter, placebo-controlled, double-blind study will evaluate the efficacy and safety of inhaled CVT 301 compared with placebo in PD patients experiencing motor response fluctuations (OFF phenomena) as an outpatient (i.e., at home) and in the clinic.

Patients who successfully complete this study will be eligible to enroll into a 12 month treatment extension (CVT-301-004E) study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

351

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A5A5
        • Acorda Site #5103
      • Ottawa, Ontario, Canada, K1Y4E9
        • Acorda Site #5104
      • Toronto, Ontario, Canada, M5T2S8
        • Acorda Site #5105
  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Acorda Site #5020
    • California
      • Fresno, California, Forenede Stater, 93710
        • Acorda Site #5042
      • Fullerton, California, Forenede Stater, 92835
        • Acorda Site #5064
      • Loma Linda, California, Forenede Stater, 92354
        • Acorda Site #5035
      • Long Beach, California, Forenede Stater, 90806
        • Acorda Site #5027
      • Los Angeles, California, Forenede Stater, 90033
        • Acorda Site #5037
      • Pasadena, California, Forenede Stater, 91105
        • Acorda Site #5070
      • Reseda, California, Forenede Stater, 91335
        • Acorda Site #5047
      • Santa Ana, California, Forenede Stater, 92705
        • Acorda Site #5068
      • Torrance, California, Forenede Stater, 90505
        • Acorda Site #5069
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20007
        • Acorda Site #5052
    • Florida
      • Atlantis, Florida, Forenede Stater, 33462
        • Acorda Site #5046
      • Aventura, Florida, Forenede Stater, 33180
        • Acorda Site #5053
      • Boca Raton, Florida, Forenede Stater, 33486
        • Acorda Site #5013
      • Jacksonville, Florida, Forenede Stater, 32209
        • Acorda Site #5016
      • Maitland, Florida, Forenede Stater, 32751
        • Acorda Site #5071
      • Orlando, Florida, Forenede Stater, 32806
        • Acorda Site #5044
      • Palm Beach Gardens, Florida, Forenede Stater, 33410
        • Acorda Site #5060
      • Port Charlotte, Florida, Forenede Stater, 33952
        • Acorda Site #5001
      • Saint Petersburg, Florida, Forenede Stater, 33713
        • Acorda Site #5065
      • Tampa, Florida, Forenede Stater, 33613
        • Acorda Site #5012
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30329
        • Acorda Site #5040
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60611
        • Acorda Site #5025
      • Chicago, Illinois, Forenede Stater, 60612
        • Acorda Site #5030
      • Elk Grove Village, Illinois, Forenede Stater, 60007
        • Acorda Site #5011
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • Acorda Site #5003
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70810
        • Acorda Site #5067
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21201
        • Acorda Site #5057
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Acorda Site #5056
      • Boston, Massachusetts, Forenede Stater, 02118
        • Acorda Site #5018
    • Michigan
      • Bingham Farms, Michigan, Forenede Stater, 48025
        • Acorda Site #5002
      • West Bloomfield, Michigan, Forenede Stater, 48322
        • Acorda Site #5014
    • Minnesota
      • Golden Valley, Minnesota, Forenede Stater, 55427
        • Acorda Site #5041
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Acorda Site #5006
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89102
        • Acorda Site #5023
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Acorda Site #5028
      • Brooklyn, New York, Forenede Stater, 11203
        • Acorda Site #5039
      • New York, New York, Forenede Stater, 10016
        • Acorda Site #5031
      • New York, New York, Forenede Stater, 10029
        • Acorda Site #5032
      • New York, New York, Forenede Stater, 10032
        • Acorda Site #5004
      • Syracuse, New York, Forenede Stater, 13210
        • Acorda Site #5038
    • North Carolina
      • Charlotte, North Carolina, Forenede Stater, 28204
        • Acorda Site #5048
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Acorda Site #5005
      • Norwood, Ohio, Forenede Stater, 45212
        • Acorda Site #5050
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Acorda Site #5062
    • Pennsylvania
      • Allentown, Pennsylvania, Forenede Stater, 18103
        • Acorda Site #5036
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • Acorda Site #5010
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Acorda Site #5058
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Acorda Site #5022
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 372322551
        • Acorda Site #5029
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Acorda Site #5019
      • Houston, Texas, Forenede Stater, 77030
        • Acorda Site #5045
    • Virginia
      • Henrico, Virginia, Forenede Stater, 23226
        • Acorda Site #5049
      • Virginia Beach, Virginia, Forenede Stater, 23456
        • Acorda Site #5059
    • Washington
      • Kirkland, Washington, Forenede Stater, 98034
        • Acorda Site #5051
  • Polen
      • Katowice, Polen, 40588
        • Acorda Site #5304
      • Krakow, Polen, 30510
        • Acorda Site #5303
      • Kraków, Polen, 30349
        • Acorda Site #5306
      • Kraków, Polen, 31505
        • Acorda Site #5307
      • Lodz, Polen, 90130
        • Acorda Site #5302
      • Warsaw, Polen, 00453
        • Acorda Site #5308
      • Warsaw, Polen, 01868
        • Acorda Site #5301
      • Zaspa, Polen, 80462
        • Acorda Site #5305
  • Spanien
      • Barcelona, Spanien, 08026
        • Acorda Site #5404
      • Barcelona, Spanien, 08035
        • Acorda Site #5406
      • Madrid, Spanien, 28006
        • Acorda Site #5405
      • San Sebastián, Spanien, 20009
        • Acorda Site #5403
      • Sant Cugat Del Vallès, Spanien, 08190
        • Acorda Site #5401
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Acorda Site #5407
  • Tjekkiet
      • Prague, Tjekkiet, 10000
        • Acorda Site #5201
      • Prague, Tjekkiet, 14000
        • Acorda Site #5203

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

30 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Idiopathic Parkinson's Disease (PD) diagnosed between the ages of 30 and 85 years;
  • Hoehn and Yahr Stage 1-3 in an "on" state;
  • Require levodopa-containing medication regimen at least 3 times during the waking day;
  • Experience motor fluctuations with a minimum of 2 hours of average daily "off" time per waking day (excluding early morning "off" time) and demonstrate levodopa responsiveness;
  • Are on stable PD medication regimen;
  • Total daily LD dose <1600 mg/day;
  • Able to perform a spirometry maneuver in the ON and OFF states;
  • Normal cognition confirmed by MMSE score ≥25

Exclusion Criteria:

  • Pregnant or lactating females;
  • Previous surgery for PD or plan to have stereotactic surgery during the study period;
  • History of psychotic symptoms requiring treatment, or suicide ideation or attempt within last year;
  • Known contraindication to the use of levodopa;
  • Any significant condition, severe concurrent disease, abnormality or finding that would make patients unsuitable or may compromise patient safety;
  • Any contraindication to performing routine spirometry.

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CVT-301 Low Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Medicin: CVT-301 Low Dose
Andre navne:
  • Inhaleret levodopa
Eksperimentel: CVT-301 High Dose
Capsules of levodopa inhalational powder used up to 5 times/day for OFF episodes for 3 months duration
Medicin: CVT-301 High Dose
Andre navne:
  • Inhaleret levodopa
Placebo komparator: Placebo
Capsules of inhalation-grade lactose used up to 5 times/day for OFF episodes for 3 months duration.
Andet: Placebo
Andre navne:
  • Laktose af inhalationskvalitet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Unified Parkinson's Disease Rating Scale (UPDRS) Part III
Tidsramme: 30 minutes post-dose at week 12
Primary Efficacy Analysis: Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 30 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
30 minutes post-dose at week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Patients Achieving Resolution of an OFF to an ON State Within 60 Minutes.
Tidsramme: at week 12
Examiner-assessed observation - Subject Achieving Resolution of an OFF to and ON state within 60 Minutes at TV4 - Observed
at week 12
UPDRS Part III Motor Score at 20 Minutes
Tidsramme: at week 12
Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 20 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population) and CVT 301 Low Dose versus Placebo. UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
at week 12
Proportion of Subjects Who Improved PGIC With CVT-301 vs. Placebo at Week 12
Tidsramme: week 12
Patient Global impression of change at treatment visit 4 (week 12) by improvement category. Seven point Likert scale ranging from 1= much worse to 7= much better.
week 12
UPDRS Part III at 10 Min.
Tidsramme: week 12
Change from Predose in the Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at 10 Minutes post-dose at Week 12 for CVT-301 High Dose versus Placebo (ITT Population). UPDRS Part III ranges from 0 minimum to 86 maximum, with lower scores indicating better movement. Units on a scale.
week 12
PD Patient Diary
Tidsramme: post week 12
Change in total daily OFF times for 3 consecutive days prior to week 12 visit compared to 3 consecutive days prior to baseline visit. Participants recorded On or Off state in 30 minute intervals during waking hours.
post week 12

Samarbejdspartnere og efterforskere

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

Sponsor

Acorda Therapeutics

Efterforskere

  • Studieleder: Charles Oh, MD, Acorda Therapeutics

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. november 2014

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

11. september 2014

Først indsendt, der opfyldte QC-kriterier

11. september 2014

Først opslået (Skøn)

15. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CVT-301-004

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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