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

NCT01060878 | Completed Phase 2 DMC

• 1 other identifier: P58/07CL/ST/09/02
• Study Type: interventional
• Target: 425
• Locations: 10 countries
• Sites: 111

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.

Conditions

Parkinson's Disease

Keywords

Early-stage

Outcome Measures

Primary Outcomes (1)

• Unified Parkinson's Disease Rating Scale parts II & III combined score

  28 Weeks

Study Arms (4)

Dose I

EXPERIMENTAL

Drug: PYM50028

Dose II

EXPERIMENTAL

Drug: PYM50028

Dose III

EXPERIMENTAL

Drug: PYM50028

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PYM50028 DRUG

IMP

Dose I; Dose II; Dose III

Placebo DRUG

Matching placebo comprising identical vehicle to active doses

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed diagnosis of early-stage idiopathic PD within the 2 years prior to screening
• subjects who are not currently receiving any PD treatment

You may not qualify if:

• female of child-bearing potential
• history of neurosurgical procedures for PD
• history of severe psychiatric illness

Sponsors & Collaborators

• Phytopharm: lead

Study Sites (111)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

University of California, Irvine

Irvine, California, 92697, United States

Location

Coastal Neurological Medical Group

La Jolla, California, 92037, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Pacific Neuroscience

Oxnard, California, 93030, United States

Location

Ellison Ambulatory Care Center

Sacramento, California, 95817, United States

Location

The Parkinson's Institute

Sunnyvale, California, 94085, United States

Location

Colorado Neurological Institute, Rocky Mountain Movement Disorders Center

Englewood, Colorado, 80113, United States

Location

Hartford Hospital

Manchester, Connecticut, 06040, United States

Location

Institute for Neurodegenerative Disorders

New Haven, Connecticut, 06510, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

University of Florida Center for Movement Disorders and Neurorestoration

Gainesville, Florida, 32607, United States

Location

Neurology Clinical Research Inc

Sunrise, Florida, 33351, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Elks Rehab - Movement Disorders Center

Boise, Idaho, 83702, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center Neuroscience Inst.

Chicago, Illinois, 60612, United States

Location

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

Location

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Henry Ford Health Center

West Bloomfield, Michigan, 48322, United States

Location

Struthers Parkinson's Center

Golden Valley, Minnesota, 55427, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Atlantic Neuroscience Institute

Morristown, New Jersey, 07902, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Weil Medical College of Cornell University

New York, New York, 10021, United States

Location

Duke Parkinson Center

Durham, North Carolina, 27705, United States

Location

University of Cincinnati Physicians

Cincinnati, Ohio, 45219, United States

Location

Neurological Institute, Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Toledo

Toledo, Ohio, 43614, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29401, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

University of Virginia Adult Neurology

Charlottesville, Virginia, 22903, United States

Location

Wisconsin Institute for Neurologic and Sleep Disorders

Milwaukee, Wisconsin, 53233, United States

Location

Glenrose Rehabilitation Hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

London Health Science Centre

London, Ontario, N6A 5A5, Canada

Location

Parkinsons Neurodegenerative Disorder Clinic

Ottawa, Ontario, K1G 3G4, Canada

Location

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Clinique Neuro-Outaouais

Gatineau, Quebec, J9J 0A5, Canada

Location

Clinique Sainte-Anne "Memoire et mouvement"

Québec, Quebec, G1S 2M5, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Fakultni nemocnice Hradec Kralove Neurologicka klinika

Hradec Králové, 500 05, Czechia

Location

Fakultni nemocnice Olomouc Neurologicka klinika

Olomouc, 799 00, Czechia

Location

Fakultní nemocnice Královské Vinohrady

Prague, 100 34, Czechia

Location

Clintrial s.r.o.

Prague, 108 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze Neurologicka klinika

Prague, 128 21, Czechia

Location

Centre Hospitalier Henri Mondor

Créteil, 94010, France

Location

CHRU de Lille

Lille, 59037, France

Location

CHU de Toulouse - Hôpital Purpan

Toulouse, 31059, France

Location

Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik

Bayern, 97080, Germany

Location

Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson

Beelitz-Heilstätten, 14547, Germany

Location

Klinik für Neurologie Charité, Universitaetsmedizin Berlin

Berlin, 13353, Germany

Location

Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

Rheinische Friedrich-Wilhelms-Universität

Bonn, 53105, Germany

Location

Klinikum-Bremerhaven Reinkenheide

Bremerhaven, 27574, Germany

Location

Neurologische Universitätsklinik, Klinikum Carl Gustav Carus

Dresden, 01307, Germany

Location

Uniklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Paracelsus-Elena-Klinik

Kassel, 34128, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Gertrudis Klinik Biskirchen

Leun-Biskirchen, 35638, Germany

Location

Neurologische Klinik Lübeck

Lübeck, 23558, Germany

Location

Philipps-Universität Marburg

Marburg, 35039, Germany

Location

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

Munich, 81675, Germany

Location

Universitätsklinikum Tübingen (UKT)

Tübingen, 72076, Germany

Location

Semmelweis Egyetem AOK Neurologiai Klinika

Budapest, 1083, Hungary

Location

Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly

Budapest, 1145, Hungary

Location

Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly

Budapest, 1204, Hungary

Location

De Oec Áok

Debrecen, 4032, Hungary

Location

Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly

Debrecen, 4043, Hungary

Location

Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly

Győr, 9023, Hungary

Location

Kaposi Mór Oktató Kórház

Kaposvár, 7400, Hungary

Location

Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly

Kecskemét, 6000, Hungary

Location

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika

Szeged, 6722, Hungary

Location

Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya

Veszprém, 8200, Hungary

Location

Zala Megyei Korhaz Neurologiai Osztaly

Zalaegerszeg, 8900, Hungary

Location

NZOZ Medica Pro Familia Sp z o o

Katowice, 40-040, Poland

Location

Małopolskie Centrum Medyczne

Krakow, 30-510, Poland

Location

Krakowska Akademia Neurologii Sp z o o

Krakow, 31-505, Poland

Location

prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski

Lodz, 90-130, Poland

Location

NZOZ Medica Pro Familia Sp z o o

Warsaw, 01-868, Poland

Location

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

Brasov, 500387, Romania

Location

Spitalul Clinic de Recuperare Cluj-Napoca

Cluj-Napoca, 400437, Romania

Location

Spitalul Clinic Cai Ferate Constanta

Constanța, 900123, Romania

Location

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

Iași, 700903, Romania

Location

Spitalul Clinic Judetean de Urgenta Timisoara

Timișoara, 300736, Romania

Location

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

Belgrade, 11000, Serbia

Location

Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju

Belgrade, 11000, Serbia

Location

Klinički centar Srbije

Belgrade, 11000, Serbia

Location

Kliničko-bolnički centar

Belgrade, 11000, Serbia

Location

Luton and Dunstable Hospital Foundation Trust

Luton, Bedfordshire, LU4 0DZ, United Kingdom

Location

Cambridge Centre for Brain Repair

Cambridge, Cambridgeshire, CB2 0PY, United Kingdom

Location

The Royal Devon and Exeter NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8BX, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, Norfolk, NR4 7UY, United Kingdom

Location

West Suffolk Hospitals NHS Trust

Bury Saint Edmonds, Suffolk, IP33 2QZ, United Kingdom

Location

Clinical Ageing Research Unit

Newcastle upon Tyne, Tyne and Wear, NE4 5PL, United Kingdom

Location

Fairfield General Hospital

Bury, BL9 7TD, United Kingdom

Location

Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Walton Centre for Neurology and Neurosurgery

Liverpool, L9 7LJ, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Salford Royal Foundation Trust

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

sarsasapogenin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2010
• First Posted: February 2, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

GB (14); HU (11); PL (5); US (41); SE (4); CZ (5); DE (15); CA (8); FR (3); RO (5)