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Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease

27. august 2009 opdateret af: Neurogen Corporation

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED)

This is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo arm. The study drug will be taken twice a day (BID). The study is blinded and neither subjects, nor the investigators, will know what treatment the subject is receiving. Investigational study drug will be adjusted to the assigned dosage and then maintained at that dosage for the balance of the 12 week follow-up period. The entire study will take about 13 weeks. The study will assess the safety and tolerability of aplindore and measure how effective aplindore is in improving movement and other effects of Parkinson disease.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

One hundred and sixty eight patients will be randomly assigned to one of four investigational treatment regimens in this outpatient study. For active treatment arms, study drug will be titrated to the assigned dosage and then maintained for up to a 12 week follow-up period before receiving tapered doses in advance of study completion. Dosing will take place over a total of about 13 weeks.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama At Birmingham (052)
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Clinic Arizona (060)
    • California
      • Sunnyvale, California, Forenede Stater, 94085
        • The Parkinson's Institute (012)
    • Colorado
      • Englewood, Colorado, Forenede Stater, 80113
        • Colorado Neurological Institute (052)
    • Connecticut
      • Danbury, Connecticut, Forenede Stater, 06810
        • Associated Neurologists, PC (190)
      • Manchester, Connecticut, Forenede Stater, 06040
        • Eastern Connecticut Neurology Specialists (215)
      • New Haven, Connecticut, Forenede Stater, 06510
        • Institute for Neurodegenerative Disorders (034)
    • Florida
      • Boca Raton, Florida, Forenede Stater, 33486
        • Parkinson's Disease & Movement Disorders Center of Boca Raton (196)
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami (014)
      • Tampa, Florida, Forenede Stater, 33606
        • University of South Florida (019)
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62794
        • Southern Illinois University (138)
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky (172)
      • Louisville, Kentucky, Forenede Stater, 40205
        • University of Louisville (087)
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70121
        • Ochsner Clinic Foundation (207)
      • Shreveport, Louisiana, Forenede Stater, 71103
        • LSU Health Science Center Shreveport (132)
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University (040)
    • Missouri
      • St Louis, Missouri, Forenede Stater, 63110
        • Washington University (027)
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Albany Medical College (037)
      • Rochester, New York, Forenede Stater, 14618
        • University of Rochester (001)
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke University Medical Center (119)
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45219
        • University of Cincinnati/Cincinnati Children's Hospital (089)
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • University of Pennsylvania (018)
    • Texas
      • Houston, Texas, Forenede Stater, 77030
        • Baylor College of Medicine (007)
    • Washington
      • Kirkland, Washington, Forenede Stater, 98034
        • Booth Gardner Parkinson's Care Center (220)
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
        • Medical College of Wisconsin (104)

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female at least 30 years old;
  • Initial diagnosis of idiopathic PD must be within 5 years;
  • At least two of the following cardinal signs must be present: bradykinesia, resting tremor, and rigidity;
  • PD progression must be Stage 1 to 2.5 (inclusive) according to the modified Hoehn and Yahr classification system;
  • Have a score on the MoCA of at least 26;
  • Have a score on the Beck Depression Inventory II (BDI II) of less than 15;
  • Have a screening UPDRS (Part III) motor score of at least 10;
  • In good general health as determined by a thorough medical history and physical examination (including vital signs), neurological examination, 12-lead ECG, and clinical chemistry laboratory tests;
  • Females of childbearing potential must be using an acceptable method of contraception and have a negative serum pregnancy test at the screening and baseline visits. Acceptable methods of contraception are oral, intrauterine, implantable, injectable contraceptives, double barrier methods or condoms impregnated with spermicide. After screening, subjects using oral contraceptive methods of contraception must agree to add an additional method until 30 days after the last dose of study medication. Women on oral contraceptives or using cervical rings must have been using them for at least 1 month before the screening visit;
  • Male subjects with partners of childbearing potential must use adequate contraception during the study and for 3 months after the study;
  • Females receiving hormone replacement therapy must be on a stable regimen for at least 3 months;
  • Able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing to comply with all study procedures.

Exclusion Criteria:

  • History or clinical features consistent with an atypical parkinsonian syndrome;
  • History of surgical intervention for PD;
  • History of severe allergic or anaphylactic reaction to any drug;
  • History of allergies or known sensitivity, hypersensitivity, or severe adverse reaction (e.g., requiring abrupt discontinuation) to any drug similar to aplindore;
  • Taking prescription drug therapy or over the counter medication for chronic medical conditions who have not been on stable doses for at least 1 month before the screening visit;
  • Treated with L-dopa within 2 months before the baseline visit or who have had cumulative treatment exceeding 2 months;
  • Have taken dopamine agonist therapy within 1 month before the baseline visit or who have taken dopamine agonist therapy for a cumulative period exceeding 2 months;
  • Are receiving amantadine, anticholinergics, or monoamine oxidase B inhibitors who have not been taking stable doses for at least 2 months before the baseline visit;
  • A clinically significantly abnormal clinical laboratory value as judged by the investigator or a value that is disapproved by the study Clinical Monitor;
  • A decrease in either systolic blood pressure of at least 40 mmHg or a decrease in diastolic blood pressure of at least 20 mmHg following 5 minutes supine and 2 minutes standing, at or within 6 months before the baseline visit;
  • Clinically significant ECG findings, including prolonged QTcF intervals (>450 msec for men, >470 msec for women);
  • Evidence of clinically significant unstable allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease;
  • History of basal or squamous cell skin cancers or carcinoma in situ of the cervix within 2 years before the screening visit are excluded; for all other cancer diagnoses, subjects with a history within 5 years before the screening visit are excluded;
  • Any condition that may significantly affect drug absorption;
  • Pregnant or lactating females;
  • History or evidence of drug abuse or alcoholism as defined by DSM-IV TR within 12 months before the baseline visit or evidence of current withdrawal from drugs or alcohol before the baseline visit;
  • Prior exposure to aplindore;
  • Received any investigational drug within 60 days before the baseline visit.

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: 4
Placebo
Medicin: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Eksperimentel: 1
aplindore 2 mg MR total daily dose
Medicin: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Eksperimentel: 2
aplindore 6 mg MR total daily dose
Medicin: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Eksperimentel: 3
aplindore 12 mg MR total daily dose
Medicin: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Mean change from baseline to end of treatment in the combined scores of Parts II and III of the UPDRS
Tidsramme: 3 months
3 months

Sekundære resultatmål

Resultatmål
Tidsramme
The responder rate; Part II and Part III scores (separately) of the UPDRS; mean change from baseline in the modified Schwab and England Activities of Daily Living; time course in UPDRS and in modified S&E-ADL; safety and tolerability of aplindore MR
Tidsramme: 3 months
3 months

Samarbejdspartnere og efterforskere

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

Sponsor

Neurogen Corporation

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. december 2008

Primær færdiggørelse (Forventet)

1. august 2009

Studieafslutning (Forventet)

1. oktober 2009

Datoer for studieregistrering

Først indsendt

15. december 2008

Først indsendt, der opfyldte QC-kriterier

15. december 2008

Først opslået (Skøn)

17. december 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. august 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2009

Sidst verificeret

1. august 2009

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Aplindore-211

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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