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

27 augustus 2009 bijgewerkt door: 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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

9

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

30 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: 4
Placebo
Geneesmiddel: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Experimenteel: 1
aplindore 2 mg MR total daily dose
Geneesmiddel: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Experimenteel: 2
aplindore 6 mg MR total daily dose
Geneesmiddel: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Experimenteel: 3
aplindore 12 mg MR total daily dose
Geneesmiddel: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
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
Tijdsspanne: 3 months
3 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Neurogen Corporation

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 december 2008

Primaire voltooiing (Verwacht)

1 augustus 2009

Studie voltooiing (Verwacht)

1 oktober 2009

Studieregistratiedata

Eerst ingediend

15 december 2008

Eerst ingediend dat voldeed aan de QC-criteria

15 december 2008

Eerst geplaatst (Schatting)

17 december 2008

Updates van studierecords

Laatste update geplaatst (Schatting)

28 augustus 2009

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2009

Laatst geverifieerd

1 augustus 2009

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Aplindore-211

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