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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose I | Experimental |
| |
| Dose II | Experimental |
| |
| Dose III | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PYM50028 | Drug | IMP |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Unified Parkinson's Disease Rating Scale parts II & III combined score | 28 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Scottsdale | Arizona | 85259 | United States | ||
| University of California, Irvine |
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| Placebo |
| Drug |
Matching placebo comprising identical vehicle to active doses |
|
| Irvine |
| California |
| 92697 |
| United States |
| Coastal Neurological Medical Group | La Jolla | California | 92037 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Pacific Neuroscience | Oxnard | California | 93030 | United States |
| Ellison Ambulatory Care Center | Sacramento | California | 95817 | United States |
| The Parkinson's Institute | Sunnyvale | California | 94085 | United States |
| Colorado Neurological Institute, Rocky Mountain Movement Disorders Center | Englewood | Colorado | 80113 | United States |
| Hartford Hospital | Manchester | Connecticut | 06040 | United States |
| Institute for Neurodegenerative Disorders | New Haven | Connecticut | 06510 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| University of Florida Center for Movement Disorders and Neurorestoration | Gainesville | Florida | 32607 | United States |
| Neurology Clinical Research Inc | Sunrise | Florida | 33351 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University | Atlanta | Georgia | 30329 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Elks Rehab - Movement Disorders Center | Boise | Idaho | 83702 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center Neuroscience Inst. | Chicago | Illinois | 60612 | United States |
| Southern Illinois University School of Medicine | Springfield | Illinois | 62794 | United States |
| The University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health Center | West Bloomfield | Michigan | 48322 | United States |
| Struthers Parkinson's Center | Golden Valley | Minnesota | 55427 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Atlantic Neuroscience Institute | Morristown | New Jersey | 07902 | United States |
| Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08901 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Weil Medical College of Cornell University | New York | New York | 10021 | United States |
| Duke Parkinson Center | Durham | North Carolina | 27705 | United States |
| University of Cincinnati Physicians | Cincinnati | Ohio | 45219 | United States |
| Neurological Institute, Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Toledo | Toledo | Ohio | 43614 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19107 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29401 | United States |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| University of Virginia Adult Neurology | Charlottesville | Virginia | 22903 | United States |
| Wisconsin Institute for Neurologic and Sleep Disorders | Milwaukee | Wisconsin | 53233 | United States |
| Glenrose Rehabilitation Hospital | Edmonton | Alberta | T5G 0B7 | Canada |
| London Health Science Centre | London | Ontario | N6A 5A5 | Canada |
| Parkinsons Neurodegenerative Disorder Clinic | Ottawa | Ontario | K1G 3G4 | Canada |
| The Ottawa Hospital - Civic Campus | Ottawa | Ontario | K1Y 4E9 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Clinique Neuro-Outaouais | Gatineau | Quebec | J9J 0A5 | Canada |
| Clinique Sainte-Anne "Memoire et mouvement" | Québec | Quebec | G1S 2M5 | Canada |
| Royal University Hospital | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| Fakultni nemocnice Hradec Kralove Neurologicka klinika | Hradec Králové | 500 05 | Czechia |
| Fakultni nemocnice Olomouc Neurologicka klinika | Olomouc | 799 00 | Czechia |
| Fakultní nemocnice Královské Vinohrady | Prague | 100 34 | Czechia |
| Clintrial s.r.o. | Prague | 108 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze Neurologicka klinika | Prague | 128 21 | Czechia |
| Centre Hospitalier Henri Mondor | Créteil | 94010 | France |
| CHRU de Lille | Lille | 59037 | France |
| CHU de Toulouse - Hôpital Purpan | Toulouse | 31059 | France |
| Universitaetsklinikum Wuerzburg Neurologische Klinik und Poliklinik | Bayern | 97080 | Germany |
| Neurologisches Fachkrankenhaus für Bewegungsstörungen / Parkinson | Beelitz-Heilstätten | 14547 | Germany |
| Klinik für Neurologie Charité, Universitaetsmedizin Berlin | Berlin | 13353 | Germany |
| Ruhr-Universität Bochum | Bochum | 44791 | Germany |
| Rheinische Friedrich-Wilhelms-Universität | Bonn | 53105 | Germany |
| Klinikum-Bremerhaven Reinkenheide | Bremerhaven | 27574 | Germany |
| Neurologische Universitätsklinik, Klinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Uniklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Paracelsus-Elena-Klinik | Kassel | 34128 | Germany |
| Universitaetsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Gertrudis Klinik Biskirchen | Leun-Biskirchen | 35638 | Germany |
| Neurologische Klinik Lübeck | Lübeck | 23558 | Germany |
| Philipps-Universität Marburg | Marburg | 35039 | Germany |
| Neurologische Klinik und Poliklinik, Klinikum Rechts der Isar TU-Muenchen | Munich | 81675 | Germany |
| Universitätsklinikum Tübingen (UKT) | Tübingen | 72076 | Germany |
| Semmelweis Egyetem AOK Neurologiai Klinika | Budapest | 1083 | Hungary |
| Fovarosi Onkormanyzat Uzsoki utcai Korhaza Neurologiai Osztaly | Budapest | 1145 | Hungary |
| Jahn Ferenc Del-pesti Korhaz Neurologiai Osztaly | Budapest | 1204 | Hungary |
| De Oec Áok | Debrecen | 4032 | Hungary |
| Kenezy Korhaz Rendelointezet Egeszsegugyi Szolgaltato Nonprofit Korlatolt Felelossegu Tarsasag Neurologiai Osztaly | Debrecen | 4043 | Hungary |
| Petz Aladar Megyei Oktato Korhaz Neurologiai Osztaly | Győr | 9023 | Hungary |
| Kaposi Mór Oktató Kórház | Kaposvár | 7400 | Hungary |
| Bacs-Kiskun Megyei Onkormanyzat Korhaza Neurologiai es Stroke Osztaly | Kecskemét | 6000 | Hungary |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Neurologiai Klinika | Szeged | 6722 | Hungary |
| Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt Ideggyogyaszati es Agyerbetegsegek Osztalya | Veszprém | 8200 | Hungary |
| Zala Megyei Korhaz Neurologiai Osztaly | Zalaegerszeg | 8900 | Hungary |
| NZOZ Medica Pro Familia Sp z o o | Katowice | 40-040 | Poland |
| Małopolskie Centrum Medyczne | Krakow | 30-510 | Poland |
| Krakowska Akademia Neurologii Sp z o o | Krakow | 31-505 | Poland |
| prof nadzw dr hab med Andrzej Bogucki Gabinet Lekarski | Lodz | 90-130 | Poland |
| NZOZ Medica Pro Familia Sp z o o | Warsaw | 01-868 | Poland |
| Cabinet Medical Individual de Neurologie Dr. Falup-Pecurariu G. Cristian-Gavril | Brasov | 500387 | Romania |
| Spitalul Clinic de Recuperare Cluj-Napoca | Cluj-Napoca | 400437 | Romania |
| Spitalul Clinic Cai Ferate Constanta | Constanța | 900123 | Romania |
| Spitalul Clinic de Urgenta "Prof. Dr. Nicolae Oblu" Iasi | Iași | 700903 | Romania |
| Spitalul Clinic Judetean de Urgenta Timisoara | Timișoara | 300736 | Romania |
| Klinicko-bolnicki centar "Bezanijska Kosa" Odeljenje za neurologiju i psihijatriju | Belgrade | 11000 | Serbia |
| Klinicko-bolnicki centar "Zvezdara" Odeljenje za neurologiju | Belgrade | 11000 | Serbia |
| Klinički centar Srbije | Belgrade | 11000 | Serbia |
| Kliničko-bolnički centar | Belgrade | 11000 | Serbia |
| Luton and Dunstable Hospital Foundation Trust | Luton | Bedfordshire | LU4 0DZ | United Kingdom |
| Cambridge Centre for Brain Repair | Cambridge | Cambridgeshire | CB2 0PY | United Kingdom |
| The Royal Devon and Exeter NHS Foundation Trust | Exeter | Devon | EX2 5DW | United Kingdom |
| Plymouth Hospitals NHS Trust | Plymouth | Devon | PL6 8BX | United Kingdom |
| Norfolk and Norwich University Hospital | Norwich | Norfolk | NR4 7UY | United Kingdom |
| West Suffolk Hospitals NHS Trust | Bury Saint Edmonds | Suffolk | IP33 2QZ | United Kingdom |
| Clinical Ageing Research Unit | Newcastle upon Tyne | Tyne and Wear | NE4 5PL | United Kingdom |
| Fairfield General Hospital | Bury | BL9 7TD | United Kingdom |
| Southern General Hospital | Glasgow | G51 4TF | United Kingdom |
| Walton Centre for Neurology and Neurosurgery | Liverpool | L9 7LJ | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| Salford Royal Foundation Trust | Salford | M6 8HD | United Kingdom |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C046297 | sarsasapogenin |
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