Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
- Registration Number
- NCT01060878
- Lead Sponsor
- Phytopharm
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 425
- confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
- subjects who are not currently receiving any PD treatment
- female of child-bearing potential
- history of neurosurgical procedures for PD
- history of severe psychiatric illness
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dose I PYM50028 - Dose III PYM50028 - Placebo Placebo - Dose II PYM50028 -
- Primary Outcome Measures
Name Time Method Unified Parkinson's Disease Rating Scale parts II & III combined score 28 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (110)
Washington University School of Medicine
πΊπΈSt. Louis, Missouri, United States
University of Pennsylvania
πΊπΈPhiladelphia, Pennsylvania, United States
Emory University
πΊπΈAtlanta, Georgia, United States
Northwestern University
πΊπΈChicago, Illinois, United States
Mayo Clinic
πΊπΈScottsdale, Arizona, United States
Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya
ππΊVeszprem, Hungary
Zala Megyei Korhaz Neurologiai Osztaly
ππΊZalaegerszeg, Hungary
Spitalul Clinic de Recuperare Cluj-Napoca
π·π΄Cluj-Napoca, Romania
Norfolk and Norwich University Hospital
π¬π§Norwich, Norfolk, United Kingdom
Hartford Hospital
πΊπΈManchester, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
πΊπΈBoca Raton, Florida, United States
University of California, Irvine
πΊπΈIrvine, California, United States
Cedars Sinai Medical Center
πΊπΈLos Angeles, California, United States
Spitalul Clinic Judetean de Urgenta Timisoara
π·π΄Timisoara, Romania
Coastal Neurological Medical Group
πΊπΈLa Jolla, California, United States
Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju
π·πΈBeograd, Serbia
Royal Free Hospital
π¬π§London, United Kingdom
KliniΔko-bolniΔki centar
π·πΈBeograd, Serbia
The Royal Devon and Exeter NHS Foundation Trust
π¬π§Exeter, Devon, United Kingdom
Plymouth Hospitals NHS Trust
π¬π§Plymouth, Devon, United Kingdom
Clinical Ageing Research Unit
π¬π§Newcastle upon Tyne, Tyne and Wear, United Kingdom
Southern General Hospital
π¬π§Glasgow, United Kingdom
Walton Centre for Neurology and Neurosurgery
π¬π§Liverpool, United Kingdom
Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi
π·π΄Iasi, Romania
KliniΔki centar Srbije
π·πΈBeograd, Serbia
Luton and Dunstable Hospital Foundation Trust
π¬π§Luton, Bedfordshire, United Kingdom
Fairfield General Hospital
π¬π§Bury, United Kingdom
Paracelsus-Elena-Klinik
π©πͺKassel, Germany
King's College Hospital
π¬π§London, United Kingdom
Spitalul Clinic Cai Ferate Constanta
π·π΄Constanta, Romania
West Suffolk Hospitals NHS Trust
π¬π§Bury St Edmonds, Suffolk, United Kingdom
Salford Royal Foundation Trust
π¬π§Salford, United Kingdom
Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju
π·πΈBeograd, Serbia
Cambridge Centre for Brain Repair
π¬π§Cambridge, Cambridgeshire, United Kingdom
Neurological Institute, Cleveland Clinic
πΊπΈCleveland, Ohio, United States
Baylor College of Medicine
πΊπΈHouston, Texas, United States
The University of Kansas Medical Center
πΊπΈKansas City, Kansas, United States
Parkinsons Neurodegenerative Disorder Clinic
π¨π¦Ottawa, Ontario, Canada
The Parkinson's Institute
πΊπΈSunnyvale, California, United States
Colorado Neurological Institute, Rocky Mountain Movement Disorders Center
πΊπΈEnglewood, Colorado, United States
Pacific Neuroscience
πΊπΈOxnard, California, United States
Elks Rehab - Movement Disorders Center
πΊπΈBoise, Idaho, United States
Neurology Clinical Research Inc
πΊπΈSunrise, Florida, United States
Medical College of Georgia
πΊπΈAugusta, Georgia, United States
Southern Illinois University School of Medicine
πΊπΈSpringfield, Illinois, United States
Henry Ford Health Center
πΊπΈWest Bloomfield, Michigan, United States
Beth Israel Deaconess Medical Center
πΊπΈBoston, Massachusetts, United States
Struthers Parkinson's Center
πΊπΈGolden Valley, Minnesota, United States
Weil Medical College of Cornell University
πΊπΈNew York, New York, United States
University of Pittsburgh
πΊπΈPittsburgh, Pennsylvania, United States
London Health Science Centre
π¨π¦London, Ontario, Canada
Toronto Western Hospital
π¨π¦Toronto, Ontario, Canada
Clinique Sainte-Anne "Memoire et mouvement"
π¨π¦Quebec City, Quebec, Canada
Clinique Neuro-Outaouais
π¨π¦Gatineau, Quebec, Canada
Royal University Hospital
π¨π¦Saskatoon, Saskatchewan, Canada
Fakultni nemocnice Olomouc Neurologicka klinika
π¨πΏOlomouc, Czech Republic
FakultnΓ nemocnice KrΓ‘lovskΓ© Vinohrady
π¨πΏPraha 10, Czech Republic
Fakultni nemocnice Hradec Kralove Neurologicka klinika
π¨πΏHradec Kralove, Czech Republic
Clintrial s.r.o.
π¨πΏPraha 10, Czech Republic
Vseobecna fakultni nemocnice v Praze Neurologicka klinika
π¨πΏPraha, Czech Republic
CHRU de Lille
π«π·Lille, France
CHU de Toulouse - HΓ΄pital Purpan
π«π·Toulouse, France
Centre Hospitalier Henri Mondor
π«π·CrΓ©teil, France
Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik
π©πͺBayern, Germany
Neurologisches Fachkrankenhaus fΓΌr BewegungsstΓΆrungen / Parkinson
π©πͺBeelitz-HeilstΓ€tten, Germany
Ruhr-UniversitΓ€t Bochum
π©πͺBochum, Germany
Klinikum-Bremerhaven Reinkenheide
π©πͺBremerhaven, Germany
Rheinische Friedrich-Wilhelms-UniversitΓ€t
π©πͺBonn, Germany
Gertrudis Klinik Biskirchen
π©πͺLeun-Biskirchen, Germany
Universitaetsklinikum Schleswig-Holstein
π©πͺKiel, Germany
Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen
π©πͺMunich, Germany
Philipps-UniversitΓ€t Marburg
π©πͺMarburg, Germany
Semmelweis Egyetem AOK Neurologiai Klinika
ππΊBudapest, Hungary
Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly
ππΊBudapest, Hungary
Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly
ππΊBudapest, Hungary
De Oec Γok
ππΊDebrecen, Hungary
Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly
ππΊDebrecen, Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly
ππΊKecskemet, Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika
ππΊSzeged, Hungary
Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
ππΊGyor, Hungary
Kaposi MΓ³r OktatΓ³ KΓ³rhΓ‘z
ππΊKaposvΓ‘r, Hungary
NZOZ Medica Pro Familia Sp z o o
π΅π±Warszawa, Poland
MaΕopolskie Centrum Medyczne
π΅π±Krakow, Poland
Krakowska Akademia Neurologii Sp z o o
π΅π±Krakow, Poland
prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski
π΅π±Lodz, Poland
Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril
π·π΄Brasov, Romania
Atlantic Neuroscience Institute
πΊπΈMorristown, New Jersey, United States
University of Virginia Adult Neurology
πΊπΈCharlottesville, Virginia, United States
Rush University Medical Center Neuroscience Inst.
πΊπΈChicago, Illinois, United States
Neurologische UniversitΓ€tsklinik, Klinikum Carl Gustav Carus
π©πͺDresden, Germany
Robert Wood Johnson Medical School
πΊπΈNew Brunswick, New Jersey, United States
University of Tennessee Health Science Center
πΊπΈMemphis, Tennessee, United States
North Shore University Hospital
πΊπΈManhasset, New York, United States
University of Cincinnati Physicians
πΊπΈCincinatti, Ohio, United States
University of Toledo
πΊπΈToledo, Ohio, United States
The Ottawa Hospital - Civic Campus
π¨π¦Ottawa, Ontario, Canada
Uniklinik Freiburg
π©πͺFreiburg, Germany
Glenrose Rehabilitation Hospital
π¨π¦Edmonton, Alberta, Canada
Klinik fΓΌr Neurologie CharitΓ©, Universitaetsmedizin Berlin
π©πͺBerlin, Germany
Neurologische Klinik LΓΌbeck
π©πͺLΓΌbeck, Germany
UniversitΓ€tsklinikum TΓΌbingen (UKT)
π©πͺTΓΌbingen, Germany
Duke Parkinson Center
πΊπΈDurham, North Carolina, United States
Ellison Ambulatory Care Center
πΊπΈSacramento, California, United States
University of South Florida
πΊπΈTampa, Florida, United States
Institute for Neurodegenerative Disorders
πΊπΈNew Haven, Connecticut, United States
University of Florida Center for Movement Disorders and Neurorestoration
πΊπΈGainesville, Florida, United States
Medical University of South Carolina
πΊπΈCharleston, South Carolina, United States
Wisconsin Institute for Neurologic and Sleep Disorders
πΊπΈMilwaukee, Wisconsin, United States
University of Utah
πΊπΈSalt Lake City, Utah, United States
Charing Cross Hospital
π¬π§London, United Kingdom