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

March 1, 2013 updated by: Phytopharm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

425

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5G 0B7
        • Glenrose Rehabilitation Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Science Centre
      • Ottawa, Ontario, Canada, K1Y 4E9
        • The Ottawa Hospital - Civic Campus
      • Ottawa, Ontario, Canada, K1G 3G4
        • Parkinsons Neurodegenerative Disorder Clinic
      • Toronto, Ontario, Canada, M5T 2S8
        • Toronto Western Hospital
    • Quebec
      • Gatineau, Quebec, Canada, J9J 0A5
        • Clinique Neuro-Outaouais
      • Quebec City, Quebec, Canada, G1S 2M5
        • Clinique Sainte-Anne "Memoire et mouvement"
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Royal University Hospital
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
        • Fakultni nemocnice Hradec Kralove Neurologicka klinika
      • Olomouc, Czech Republic, 799 00
        • Fakultni nemocnice Olomouc Neurologicka klinika
      • Praha, Czech Republic, 128 21
        • Vseobecna fakultni nemocnice v Praze Neurologicka klinika
      • Praha 10, Czech Republic, 100 34
        • Fakultní nemocnice Královské Vinohrady
      • Praha 10, Czech Republic, 108 00
        • Clintrial s.r.o.
  • France
      • Créteil, France, 94010
        • Centre Hospitalier Henri Mondor
      • Lille, France, 59037
        • CHRU de Lille
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Purpan
  • Germany
      • Bayern, Germany, 97080
        • Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik
      • Beelitz-Heilstätten, Germany, 14547
        • Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson
      • Berlin, Germany, 13353
        • Klinik für Neurologie Charité, Universitaetsmedizin Berlin
      • Bochum, Germany, 44791
        • Ruhr-Universität Bochum
      • Bonn, Germany, 53105
        • Rheinische Friedrich-Wilhelms-Universitat
      • Bremerhaven, Germany, 27574
        • Klinikum-Bremerhaven Reinkenheide
      • Dresden, Germany, 01307
        • Neurologische Universitätsklinik, Klinikum Carl Gustav Carus
      • Freiburg, Germany, 79106
        • Uniklinik Freiburg
      • Kassel, Germany, 34128
        • Paracelsus-Elena-Klinik
      • Kiel, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein
      • Leun-Biskirchen, Germany, 35638
        • Gertrudis Klinik Biskirchen
      • Lübeck, Germany, 23558
        • Neurologische Klinik Lübeck
      • Marburg, Germany, 35039
        • Philipps-Universitat Marburg
      • Munich, Germany, 81675
        • Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen
      • Tübingen, Germany, 72076
        • Universitätsklinikum Tübingen (UKT)
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem AOK Neurologiai Klinika
      • Budapest, Hungary, 1145
        • Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly
      • Budapest, Hungary, 1204
        • Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly
      • Debrecen, Hungary, 4032
        • De Oec Áok
      • Debrecen, Hungary, 4043
        • Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly
      • Gyor, Hungary, 9023
        • Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly
      • Kaposvár, Hungary, 7400
        • Kaposi Mór Oktató Kórház
      • Kecskemet, Hungary, 6000
        • Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly
      • Szeged, Hungary, 6722
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika
      • Veszprem, Hungary, 8200
        • Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya
      • Zalaegerszeg, Hungary, 8900
        • Zala Megyei Korhaz Neurologiai Osztaly
  • Poland
      • Katowice, Poland, 40-040
        • NZOZ Medica Pro Familia Sp z o o
      • Krakow, Poland, 30-510
        • Małopolskie Centrum Medyczne
      • Krakow, Poland, 31-505
        • Krakowska Akademia Neurologii Sp z o o
      • Lodz, Poland, 90-130
        • prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski
      • Warszawa, Poland, 01-868
        • NZOZ Medica Pro Familia Sp z o o
  • Romania
      • Brasov, Romania, 500387
        • Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril
      • Cluj-Napoca, Romania, 400437
        • Spitalul Clinic de Recuperare Cluj-Napoca
      • Constanta, Romania, 900123
        • Spitalul Clinic Cai Ferate Constanta
      • Iasi, Romania, 700903
        • Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi
      • Timisoara, Romania, 300736
        • Spitalul Clinic Judetean de Urgenta Timisoara
  • Serbia
      • Beograd, Serbia, 11000
        • Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju
      • Beograd, Serbia, 11000
        • Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju
      • Beograd, Serbia, 11000
        • Klinicki Centar Srbije
      • Beograd, Serbia, 11000
        • Kliničko-bolnički centar
  • United Kingdom
      • Bury, United Kingdom, BL9 7TD
        • Fairfield General Hospital
      • Glasgow, United Kingdom, G51 4TF
        • Southern General Hospital
      • Liverpool, United Kingdom, L9 7LJ
        • Walton Centre For Neurology and Neurosurgery
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, NW3 2QG
        • Royal Free Hospital
      • London, United Kingdom, W6 8RF
        • Charing Cross Hospital
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Foundation Trust
    • Bedfordshire
      • Luton, Bedfordshire, United Kingdom, LU4 0DZ
        • Luton and Dunstable Hospital Foundation Trust
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0PY
        • Cambridge Centre for Brain Repair
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
        • The Royal Devon and Exeter NHS Foundation Trust
      • Plymouth, Devon, United Kingdom, PL6 8BX
        • Plymouth Hospitals NHS Trust
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital
    • Suffolk
      • Bury St Edmonds, Suffolk, United Kingdom, IP33 2QZ
        • West Suffolk Hospitals NHS Trust
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE4 5PL
        • Clinical Ageing research Unit
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • Irvine, California, United States, 92697
        • University of California, Irvine
      • La Jolla, California, United States, 92037
        • Coastal Neurological Medical Group
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Oxnard, California, United States, 93030
        • Pacific Neuroscience
      • Sacramento, California, United States, 95817
        • Ellison Ambulatory Care Center
      • Sunnyvale, California, United States, 94085
        • The Parkinson's Institute
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Colorado Neurological Institute, Rocky Mountain Movement Disorders Center
    • Connecticut
      • Manchester, Connecticut, United States, 06040
        • Hartford Hospital
      • New Haven, Connecticut, United States, 06510
        • Institute for Neurodegenerative Disorders
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
      • Gainesville, Florida, United States, 32607
        • University of Florida Center for Movement Disorders and Neurorestoration
      • Sunrise, Florida, United States, 33351
        • Neurology Clinical Research Inc
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Idaho
      • Boise, Idaho, United States, 83702
        • Elks Rehab - Movement Disorders Center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center Neuroscience Inst.
      • Springfield, Illinois, United States, 62794
        • Southern Illinois University School of Medicine
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • The University of Kansas Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
    • Michigan
      • West Bloomfield, Michigan, United States, 48322
        • Henry Ford Health Center
    • Minnesota
      • Golden Valley, Minnesota, United States, 55427
        • Struthers Parkinson's Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Morristown, New Jersey, United States, 07902
        • Atlantic Neuroscience Institute
      • New Brunswick, New Jersey, United States, 08901
        • Robert Wood Johnson Medical School
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10021
        • Weil Medical College of Cornell University
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Parkinson Center
    • Ohio
      • Cincinatti, Ohio, United States, 45219
        • University of Cincinnati Physicians
      • Cleveland, Ohio, United States, 44195
        • Neurological Institute, Cleveland Clinic
      • Toledo, Ohio, United States, 43614
        • University of Toledo
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • University of Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • University of Pittsburgh
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Adult Neurology
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Wisconsin Institute for Neurologic and Sleep Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Matching placebo comprising identical vehicle to active doses
EXPERIMENTAL: Dose I
Drug: PYM50028
IMP
EXPERIMENTAL: Dose II
Drug: PYM50028
IMP
EXPERIMENTAL: Dose III
Drug: PYM50028
IMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Unified Parkinson's Disease Rating Scale parts II & III combined score
Time Frame: 28 Weeks
28 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phytopharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (ESTIMATE)

February 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P58/07CL/ST/09/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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