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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Phytopharm
ClinicalTrials.gov Identifier:
NCT01060878
First received: February 1, 2010
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: PYM50028
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Phytopharm:

Primary Outcome Measures:
  • Unified Parkinson's Disease Rating Scale parts II & III combined score [ Time Frame: 28 Weeks ] [ Designated as safety issue: No ]

Enrollment: 425
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose I Drug: PYM50028
IMP
Experimental: Dose II Drug: PYM50028
IMP
Experimental: Dose III Drug: PYM50028
IMP
Placebo Comparator: Placebo Drug: Placebo
Matching placebo comprising identical vehicle to active doses

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060878

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

No publications provided

Responsible Party: Phytopharm
ClinicalTrials.gov Identifier: NCT01060878     History of Changes
Other Study ID Numbers: P58/07CL/ST/09/02
Study First Received: February 1, 2010
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Phytopharm:
Early-stage

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 23, 2014