Clinical trial NCT01060878: Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Keywords: Early-stage
Lead sponsor: Phytopharm
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 425
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Unified Parkinson's Disease Rating Scale parts II & III combined score
timeFrame: 28 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic
state: Arizona
city: Irvine
country: United States
facility: University of California, Irvine
state: California
city: La Jolla
country: United States
facility: Coastal Neurological Medical Group
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience
state: California
city: Sacramento
country: United States
facility: Ellison Ambulatory Care Center
state: California
city: Sunnyvale
country: United States
facility: The Parkinson's Institute
state: California
city: Englewood
country: United States
facility: Colorado Neurological Institute, Rocky Mountain Movement Disorders Center
state: Colorado
city: Manchester
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: University of Florida Center for Movement Disorders and Neurorestoration
state: Florida
city: Sunrise
country: United States
facility: Neurology Clinical Research Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Boise
country: United States
facility: Elks Rehab - Movement Disorders Center
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center Neuroscience Inst.
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: West Bloomfield
country: United States
facility: Henry Ford Health Center
state: Michigan
city: Golden Valley
country: United States
facility: Struthers Parkinson's Center
state: Minnesota
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Morristown
country: United States
facility: Atlantic Neuroscience Institute
state: New Jersey
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: New York
country: United States
facility: Weil Medical College of Cornell University
state: New York
city: Durham
country: United States
facility: Duke Parkinson Center
state: North Carolina
city: Cincinatti
country: United States
facility: University of Cincinnati Physicians
state: Ohio
city: Cleveland
country: United States
facility: Neurological Institute, Cleveland Clinic
state: Ohio
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Adult Neurology
state: Virginia
city: Milwaukee
country: United States
facility: Wisconsin Institute for Neurologic and Sleep Disorders
state: Wisconsin
city: Edmonton
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: Parkinsons Neurodegenerative Disorder Clinic
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
city: Gatineau
country: Canada
facility: Clinique Neuro-Outaouais
state: Quebec
city: Quebec City
country: Canada
facility: Clinique Sainte-Anne "Memoire et mouvement"
state: Quebec
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Hradec Kralove
country: Czech Republic
facility: Fakultni nemocnice Hradec Kralove Neurologicka klinika
city: Olomouc
country: Czech Republic
facility: Fakultni nemocnice Olomouc Neurologicka klinika
city: Praha 10
country: Czech Republic
facility: Fakultní nemocnice Královské Vinohrady
city: Praha 10
country: Czech Republic
facility: Clintrial s.r.o.
city: Praha
country: Czech Republic
facility: Vseobecna fakultni nemocnice v Praze Neurologicka klinika
city: Créteil
country: France
facility: Centre Hospitalier Henri Mondor
city: Lille
country: France
facility: CHRU de Lille
city: Toulouse
country: France
facility: CHU de Toulouse - Hôpital Purpan
city: Bayern
country: Germany
facility: Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik
city: Beelitz-Heilstätten
country: Germany
facility: Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson
city: Berlin
country: Germany
facility: Klinik für Neurologie Charité, Universitaetsmedizin Berlin
city: Bochum
country: Germany
facility: Ruhr-Universität Bochum
city: Bonn
country: Germany
facility: Rheinische Friedrich-Wilhelms-Universität
city: Bremerhaven
country: Germany
facility: Klinikum-Bremerhaven Reinkenheide
city: Dresden
country: Germany
facility: Neurologische Universitätsklinik, Klinikum Carl Gustav Carus
city: Freiburg
country: Germany
facility: Uniklinik Freiburg
city: Kassel
country: Germany
facility: Paracelsus-Elena-Klinik
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Leun-Biskirchen
country: Germany
facility: Gertrudis Klinik Biskirchen
city: Lübeck
country: Germany
facility: Neurologische Klinik Lübeck
city: Marburg
country: Germany
facility: Philipps-Universität Marburg
city: Munich
country: Germany
facility: Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen (UKT)
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK Neurologiai Klinika
city: Budapest
country: Hungary
facility: Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly
city: Debrecen
country: Hungary
facility: De Oec Áok
city: Debrecen
country: Hungary
facility: Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
city: Kaposvár
country: Hungary
facility: Kaposi Mór Oktató Kórház
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika
city: Veszprem
country: Hungary
facility: Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya
city: Zalaegerszeg
country: Hungary
facility: Zala Megyei Korhaz Neurologiai Osztaly
city: Katowice
country: Poland
facility: NZOZ Medica Pro Familia Sp z o o
city: Krakow
country: Poland
facility: Małopolskie Centrum Medyczne
city: Krakow
country: Poland
facility: Krakowska Akademia Neurologii Sp z o o
city: Lodz
country: Poland
facility: prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski
city: Warszawa
country: Poland
facility: NZOZ Medica Pro Familia Sp z o o
city: Brasov
country: Romania
facility: Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic de Recuperare Cluj-Napoca
city: Constanta
country: Romania
facility: Spitalul Clinic Cai Ferate Constanta
city: Iasi
country: Romania
facility: Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi
city: Timisoara
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Timisoara
city: Beograd
country: Serbia
facility: Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju
city: Beograd
country: Serbia
facility: Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju
city: Beograd
country: Serbia
facility: Klinički centar Srbije
city: Beograd
country: Serbia
facility: Kliničko-bolnički centar
city: Luton
country: United Kingdom
facility: Luton and Dunstable Hospital Foundation Trust
state: Bedfordshire
city: Cambridge
country: United Kingdom
facility: Cambridge Centre for Brain Repair
state: Cambridgeshire
city: Exeter
country: United Kingdom
facility: The Royal Devon and Exeter NHS Foundation Trust
state: Devon
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
state: Norfolk
city: Bury St Edmonds
country: United Kingdom
facility: West Suffolk Hospitals NHS Trust
state: Suffolk
city: Newcastle upon Tyne
country: United Kingdom
facility: Clinical Ageing Research Unit
state: Tyne and Wear
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
city: Glasgow
country: United Kingdom
facility: Southern General Hospital
city: Liverpool
country: United Kingdom
facility: Walton Centre for Neurology and Neurosurgery
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Salford
country: United Kingdom
facility: Salford Royal Foundation Trust
Study officials:
References: