Parkinson's Disease Clinical Trial
— CONFIDENT-PDOfficial title:
Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 Weeks
A study to test the therapeutic benefit of the compound PYM50028, versus placebo, in treating early-stage Parkinson's disease. Therapeutic benefit will be assessed using the Unified Parkinson's Disease Rating Scale (UPDRS). It is hypothesised that PYM50028 will be safe and well tolerated in this study and demonstrate therapeutic benefit in this patient population.
Status | Completed |
Enrollment | 425 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 75 Years |
Eligibility |
Inclusion Criteria: - confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening - subjects who are not currently receiving any PD treatment Exclusion Criteria: - female of child-bearing potential - history of neurosurgical procedures for PD - history of severe psychiatric illness |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Glenrose Rehabilitation Hospital | Edmonton | Alberta |
Canada | Clinique Neuro-Outaouais | Gatineau | Quebec |
Canada | London Health Science Centre | London | Ontario |
Canada | Parkinsons Neurodegenerative Disorder Clinic | Ottawa | Ontario |
Canada | The Ottawa Hospital - Civic Campus | Ottawa | Ontario |
Canada | Clinique Sainte-Anne "Memoire et mouvement" | Quebec City | Quebec |
Canada | Royal University Hospital | Saskatoon | Saskatchewan |
Canada | Toronto Western Hospital | Toronto | Ontario |
Czech Republic | Fakultni nemocnice Hradec Kralove Neurologicka klinika | Hradec Kralove | |
Czech Republic | Fakultni nemocnice Olomouc Neurologicka klinika | Olomouc | |
Czech Republic | Vseobecna fakultni nemocnice v Praze Neurologicka klinika | Praha | |
Czech Republic | Clintrial s.r.o. | Praha 10 | |
Czech Republic | Fakultní nemocnice Královské Vinohrady | Praha 10 | |
France | Centre Hospitalier Henri Mondor | Créteil | |
France | CHRU de Lille | Lille | |
France | CHU de Toulouse - Hôpital Purpan | Toulouse | |
Germany | Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik | Bayern | |
Germany | Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson | Beelitz-Heilstätten | |
Germany | Klinik für Neurologie Charité, Universitaetsmedizin Berlin | Berlin | |
Germany | Ruhr-Universität Bochum | Bochum | |
Germany | Rheinische Friedrich-Wilhelms-Universität | Bonn | |
Germany | Klinikum-Bremerhaven Reinkenheide | Bremerhaven | |
Germany | Neurologische Universitätsklinik, Klinikum Carl Gustav Carus | Dresden | |
Germany | Uniklinik Freiburg | Freiburg | |
Germany | Paracelsus-Elena-Klinik | Kassel | |
Germany | Universitaetsklinikum Schleswig-Holstein | Kiel | |
Germany | Gertrudis Klinik Biskirchen | Leun-Biskirchen | |
Germany | Neurologische Klinik Lübeck | Lübeck | |
Germany | Philipps-Universität Marburg | Marburg | |
Germany | Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen | Munich | |
Germany | Universitätsklinikum Tübingen (UKT) | Tübingen | |
Hungary | Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly | Budapest | |
Hungary | Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly | Budapest | |
Hungary | Semmelweis Egyetem AOK Neurologiai Klinika | Budapest | |
Hungary | De Oec Áok | Debrecen | |
Hungary | Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly | Debrecen | |
Hungary | Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly | Gyor | |
Hungary | Kaposi Mór Oktató Kórház | Kaposvár | |
Hungary | Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly | Kecskemet | |
Hungary | Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika | Szeged | |
Hungary | Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya | Veszprem | |
Hungary | Zala Megyei Korhaz Neurologiai Osztaly | Zalaegerszeg | |
Poland | NZOZ Medica Pro Familia Sp z o o | Katowice | |
Poland | Krakowska Akademia Neurologii Sp z o o | Krakow | |
Poland | Malopolskie Centrum Medyczne | Krakow | |
Poland | prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski | Lodz | |
Poland | NZOZ Medica Pro Familia Sp z o o | Warszawa | |
Romania | Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril | Brasov | |
Romania | Spitalul Clinic de Recuperare Cluj-Napoca | Cluj-Napoca | |
Romania | Spitalul Clinic Cai Ferate Constanta | Constanta | |
Romania | Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi | Iasi | |
Romania | Spitalul Clinic Judetean de Urgenta Timisoara | Timisoara | |
Serbia | Klinicki centar Srbije | Beograd | |
Serbia | Klinicko-bolnicki centar | Beograd | |
Serbia | Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju | Beograd | |
Serbia | Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju | Beograd | |
United Kingdom | Fairfield General Hospital | Bury | |
United Kingdom | West Suffolk Hospitals NHS Trust | Bury St Edmonds | Suffolk |
United Kingdom | Cambridge Centre for Brain Repair | Cambridge | Cambridgeshire |
United Kingdom | The Royal Devon and Exeter NHS Foundation Trust | Exeter | Devon |
United Kingdom | Southern General Hospital | Glasgow | |
United Kingdom | Walton Centre for Neurology and Neurosurgery | Liverpool | |
United Kingdom | Charing Cross Hospital | London | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | Luton and Dunstable Hospital Foundation Trust | Luton | Bedfordshire |
United Kingdom | Clinical Ageing Research Unit | Newcastle upon Tyne | Tyne and Wear |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | Norfolk |
United Kingdom | Plymouth Hospitals NHS Trust | Plymouth | Devon |
United Kingdom | Salford Royal Foundation Trust | Salford | |
United States | Emory University | Atlanta | Georgia |
United States | Medical College of Georgia | Augusta | Georgia |
United States | Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida |
United States | Elks Rehab - Movement Disorders Center | Boise | Idaho |
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | University of Virginia Adult Neurology | Charlottesville | Virginia |
United States | Northwestern University | Chicago | Illinois |
United States | Rush University Medical Center Neuroscience Inst. | Chicago | Illinois |
United States | University of Cincinnati Physicians | Cincinatti | Ohio |
United States | Neurological Institute, Cleveland Clinic | Cleveland | Ohio |
United States | Duke Parkinson Center | Durham | North Carolina |
United States | Colorado Neurological Institute, Rocky Mountain Movement Disorders Center | Englewood | Colorado |
United States | University of Florida Center for Movement Disorders and Neurorestoration | Gainesville | Florida |
United States | Struthers Parkinson's Center | Golden Valley | Minnesota |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of California, Irvine | Irvine | California |
United States | The University of Kansas Medical Center | Kansas City | Kansas |
United States | Coastal Neurological Medical Group | La Jolla | California |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Hartford Hospital | Manchester | Connecticut |
United States | North Shore University Hospital | Manhasset | New York |
United States | University of Tennessee Health Science Center | Memphis | Tennessee |
United States | Wisconsin Institute for Neurologic and Sleep Disorders | Milwaukee | Wisconsin |
United States | Atlantic Neuroscience Institute | Morristown | New Jersey |
United States | Robert Wood Johnson Medical School | New Brunswick | New Jersey |
United States | Institute for Neurodegenerative Disorders | New Haven | Connecticut |
United States | Weil Medical College of Cornell University | New York | New York |
United States | Pacific Neuroscience | Oxnard | California |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Ellison Ambulatory Care Center | Sacramento | California |
United States | University of Utah | Salt Lake City | Utah |
United States | Mayo Clinic | Scottsdale | Arizona |
United States | Southern Illinois University School of Medicine | Springfield | Illinois |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | The Parkinson's Institute | Sunnyvale | California |
United States | Neurology Clinical Research Inc | Sunrise | Florida |
United States | University of South Florida | Tampa | Florida |
United States | University of Toledo | Toledo | Ohio |
United States | Henry Ford Health Center | West Bloomfield | Michigan |
Lead Sponsor | Collaborator |
---|---|
Phytopharm |
United States, Canada, Czech Republic, France, Germany, Hungary, Poland, Romania, Serbia, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Unified Parkinson's Disease Rating Scale parts II & III combined score | 28 Weeks | No |
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