Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)

Parkinson's Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060878
• Other study ID #: P58/07CL/ST/09/02
• Status: Completed
• Phase: Phase 2
• First received: February 1, 2010
• Last updated: March 1, 2013
• Start date: November 2010
• Est. completion date: December 2012

Study information

• Verified date: March 2013
• Source: Phytopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCanada: Health CanadaFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• PYM50028
IMP
• Placebo
Matching placebo comprising identical vehicle to active doses

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Phytopharm

Countries where clinical trial is conducted

United States,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Poland,  Romania,  Serbia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Unified Parkinson's Disease Rating Scale parts II & III combined score		28 Weeks	No