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

27 agosto 2009 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

9

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

30 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: 4
Placebo
Droga: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Sperimentale: 1
aplindore 2 mg MR total daily dose
Droga: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Sperimentale: 2
aplindore 6 mg MR total daily dose
Droga: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks
Sperimentale: 3
aplindore 12 mg MR total daily dose
Droga: aplindore MR tablets or Placebo
aplindore MR tablets administered BID for about 13 weeks

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Mean change from baseline to end of treatment in the combined scores of Parts II and III of the UPDRS
Lasso di tempo: 3 months
3 months

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
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
Lasso di tempo: 3 months
3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Neurogen Corporation

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 dicembre 2008

Completamento primario (Anticipato)

1 agosto 2009

Completamento dello studio (Anticipato)

1 ottobre 2009

Date di iscrizione allo studio

Primo inviato

15 dicembre 2008

Primo inviato che soddisfa i criteri di controllo qualità

15 dicembre 2008

Primo Inserito (Stima)

17 dicembre 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

28 agosto 2009

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 agosto 2009

Ultimo verificato

1 agosto 2009

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • Aplindore-211

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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