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

NCT ID: NCT01060878

Last Updated: 2013-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

425 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose I

Group Type EXPERIMENTAL

PYM50028

Intervention Type DRUG

IMP

Dose II

Group Type EXPERIMENTAL

PYM50028

Intervention Type DRUG

IMP

Dose III

Group Type EXPERIMENTAL

PYM50028

Intervention Type DRUG

IMP

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo comprising identical vehicle to active doses

Interventions

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PYM50028

IMP

Intervention Type DRUG

Placebo

Matching placebo comprising identical vehicle to active doses

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Phytopharm

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic

Scottsdale, Arizona, United States

Site Status

University of California, Irvine

Irvine, California, United States

Site Status

Coastal Neurological Medical Group

La Jolla, California, United States

Site Status

Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Pacific Neuroscience

Oxnard, California, United States

Site Status

Ellison Ambulatory Care Center

Sacramento, California, United States

Site Status

The Parkinson's Institute

Sunnyvale, California, United States

Site Status

Colorado Neurological Institute, Rocky Mountain Movement Disorders Center

Englewood, Colorado, United States

Site Status

Hartford Hospital

Manchester, Connecticut, United States

Site Status

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Site Status

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Site Status

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, United States

Site Status

Neurology Clinical Research Inc

Sunrise, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

Elks Rehab - Movement Disorders Center

Boise, Idaho, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Rush University Medical Center Neuroscience Inst.

Chicago, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

The University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Henry Ford Health Center

West Bloomfield, Michigan, United States

Site Status

Struthers Parkinson's Center

Golden Valley, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Atlantic Neuroscience Institute

Morristown, New Jersey, United States

Site Status

Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

North Shore University Hospital

Manhasset, New York, United States

Site Status

Weil Medical College of Cornell University

New York, New York, United States

Site Status

Duke Parkinson Center

Durham, North Carolina, United States

Site Status

University of Cincinnati Physicians

Cincinnati, Ohio, United States

Site Status

Neurological Institute, Cleveland Clinic

Cleveland, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Virginia Adult Neurology

Charlottesville, Virginia, United States

Site Status

Wisconsin Institute for Neurologic and Sleep Disorders

Milwaukee, Wisconsin, United States

Site Status

Glenrose Rehabilitation Hospital

Edmonton, Alberta, Canada

Site Status

London Health Science Centre

London, Ontario, Canada

Site Status

Parkinsons Neurodegenerative Disorder Clinic

Ottawa, Ontario, Canada

Site Status

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, Canada

Site Status

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status

Clinique Neuro-Outaouais

Gatineau, Quebec, Canada

Site Status

Clinique Sainte-Anne "Memoire et mouvement"

Québec, Quebec, Canada

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Fakultni nemocnice Hradec Kralove Neurologicka klinika

Hradec Králové, , Czechia

Site Status

Fakultni nemocnice Olomouc Neurologicka klinika

Olomouc, , Czechia

Site Status

Fakultní nemocnice Královské Vinohrady

Prague, , Czechia

Site Status

Clintrial s.r.o.

Prague, , Czechia

Site Status

Vseobecna fakultni nemocnice v Praze Neurologicka klinika

Prague, , Czechia

Site Status

Centre Hospitalier Henri Mondor

Créteil, , France

Site Status

CHRU de Lille

Lille, , France

Site Status

CHU de Toulouse - Hôpital Purpan

Toulouse, , France

Site Status

Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik

Bayern, , Germany

Site Status

Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

Beelitz-Heilstätten, , Germany

Site Status

Klinik für Neurologie Charité, Universitaetsmedizin Berlin

Berlin, , Germany

Site Status

Ruhr-Universität Bochum

Bochum, , Germany

Site Status

Rheinische Friedrich-Wilhelms-Universität

Bonn, , Germany

Site Status

Klinikum-Bremerhaven Reinkenheide

Bremerhaven, , Germany

Site Status

Neurologische Universitätsklinik, Klinikum Carl Gustav Carus

Dresden, , Germany

Site Status

Uniklinik Freiburg

Freiburg im Breisgau, , Germany

Site Status

Paracelsus-Elena-Klinik

Kassel, , Germany

Site Status

Universitaetsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status

Gertrudis Klinik Biskirchen

Leun-Biskirchen, , Germany

Site Status

Neurologische Klinik Lübeck

Lübeck, , Germany

Site Status

Philipps-Universität Marburg

Marburg, , Germany

Site Status

Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen

Munich, , Germany

Site Status

Universitätsklinikum Tübingen (UKT)

Tübingen, , Germany

Site Status

Semmelweis Egyetem AOK Neurologiai Klinika

Budapest, , Hungary

Site Status

Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly

Budapest, , Hungary

Site Status

Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly

Budapest, , Hungary

Site Status

De Oec Áok

Debrecen, , Hungary

Site Status

Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly

Debrecen, , Hungary

Site Status

Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

Győr, , Hungary

Site Status

Kaposi Mór Oktató Kórház

Kaposvár, , Hungary

Site Status

Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly

Kecskemét, , Hungary

Site Status

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika

Szeged, , Hungary

Site Status

Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya

Veszprém, , Hungary

Site Status

Zala Megyei Korhaz Neurologiai Osztaly

Zalaegerszeg, , Hungary

Site Status

NZOZ Medica Pro Familia Sp z o o

Katowice, , Poland

Site Status

Małopolskie Centrum Medyczne

Krakow, , Poland

Site Status

Krakowska Akademia Neurologii Sp z o o

Krakow, , Poland

Site Status

prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski

Lodz, , Poland

Site Status

NZOZ Medica Pro Familia Sp z o o

Warsaw, , Poland

Site Status

Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril

Brasov, , Romania

Site Status

Spitalul Clinic de Recuperare Cluj-Napoca

Cluj-Napoca, , Romania

Site Status

Spitalul Clinic Cai Ferate Constanta

Constanța, , Romania

Site Status

Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi

Iași, , Romania

Site Status

Spitalul Clinic Judetean de Urgenta Timisoara

Timișoara, , Romania

Site Status

Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju

Belgrade, , Serbia

Site Status

Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju

Belgrade, , Serbia

Site Status

Klinički centar Srbije

Belgrade, , Serbia

Site Status

Kliničko-bolnički centar

Belgrade, , Serbia

Site Status

Luton and Dunstable Hospital Foundation Trust

Luton, Bedfordshire, United Kingdom

Site Status

Cambridge Centre for Brain Repair

Cambridge, Cambridgeshire, United Kingdom

Site Status

The Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, United Kingdom

Site Status

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, Norfolk, United Kingdom

Site Status

West Suffolk Hospitals NHS Trust

Bury Saint Edmonds, Suffolk, United Kingdom

Site Status

Clinical Ageing Research Unit

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Site Status

Fairfield General Hospital

Bury, , United Kingdom

Site Status

Southern General Hospital

Glasgow, , United Kingdom

Site Status

Walton Centre for Neurology and Neurosurgery

Liverpool, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Salford Royal Foundation Trust

Salford, , United Kingdom

Site Status

Countries

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United States Canada Czechia France Germany Hungary Poland Romania Serbia United Kingdom

Other Identifiers

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P58/07CL/ST/09/02

Identifier Type: -

Identifier Source: org_study_id

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