PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706
- Registration Number
- NCT03655236
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
This study consists of 2 parts. Part 1 of the study is conducted to evaluate the efficacy, safety, and tolerability of two doses of K0706 compared to placebo in subjects with early Parkinson's Disease who are not receiving dopaminergic therapy. Part 2 is an optional long term extension study for subjects who have completed week 40 of Part 1
- Detailed Description
This study is designed to assess the ability of K0706 to slow the progression of PD. Preclinical animal model data have already demonstrated that K0706 has neuroprotective activity, but further development will require human clinical experience.
This study will also allow determination of safety and tolerability of K0706 over many months in subjects with PD.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 513
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description K0706, low dose K0706 - K0706, high dose K0706 - Placebo placebo -
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events Week 80 Change from baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score. Week 40 Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.
- Secondary Outcome Measures
Name Time Method Change in health related quality of life as measured by the European quality of life questionnaire 5 level version Week 40 Level of K0706 Week 40 Part 1: Change from baseline to Week 40 in the sum of the MDS-UPDRS Parts II and III total scores Part 2: Change from Week 40 to Week 76 in the sum of the MDS-UPDRS Part III scores Part 1: Week 40 and Part 2: Week 76 Change in the scales for outcomes in Parkinson's disease - autonomic questionnaire Week 40 Time from first dose in Part 1 to initiation of symptomatic PD medications Part 1: Week 40 and Part 2: Week 80 Change in Clinician global impression severity Week 40
Trial Locations
- Locations (77)
Keck Hospital of USC
🇺🇸Los Angeles, California, United States
SINGUA Sp. Z o.o.
🇵🇱Warszawa, Mazowieckie, Poland
Neuro-Care - Sp. z o.o. Sp. Komandytowa Ul. Szpitalna 6
🇵🇱Siemianowice Śląskie, Slaskie, Poland
Baylor College of Medicine (BCM)- Parkinson's Disease Center and Movement Disorders Clinic (PDCMDC)
🇺🇸Houston, Texas, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
Jaslok Hospital and Research centre
🇮🇳Mumbai, Maharashtra, India
MUDr. Beata Dupejova, neurologicka ambulancia s.r.o
🇸🇰Banska Bystrica, Slovakia
Visionary Investigators Network
🇺🇸Miami, Florida, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
University of Arkansas for Medical Sciences (UAMS) - Movement Disorders Clinic
🇺🇸Little Rock, Arkansas, United States
Dartmouth-Hitchcock Medical Center (DHMC) Neurology Research
🇺🇸Lebanon, New Hampshire, United States
Henry Ford West Bloomfield Hospital
🇺🇸West Bloomfield, Michigan, United States
Medsol Clinical Research Center
🇺🇸Port Charlotte, Florida, United States
Szent Borbála Kórház
🇭🇺Tatabánya, Komarom-Esztergom, Hungary
Pest Megyei Flór Ferenc Kórház
🇭🇺Kistarcsa, Pest, Hungary
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Nasz Lekarz Przychodnie Medyczne Ośrodek Badań Klinicznych
🇵🇱Toruń, Kujawsko-Pomorskie, Poland
Robert Wood Johnson Medical School Department of Neurology, Clinical Academic Building (CAB)
🇺🇸New Brunswick, New Jersey, United States
P.D. Hinduja National Hospital and Medical Care Research Centre
🇮🇳Mumbai, Maharastra, India
Fortis Flt. Lt. Rajan Dhall Hospital
🇮🇳Vasant Kunj, New Delhi, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, India
Deenanath Mangeshkar Hospital & Research Center (DMHRC)
🇮🇳Pune, India
SOMED CR
🇵🇱Łódź, Lodzkie, Poland
ETG Lublin
🇵🇱Lublin, Lubelskie, Poland
Neurology Associates PA
🇺🇸Maitland, Florida, United States
Medipoint Hospital
🇮🇳Aundh, Pune, India
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
NZOZ Neuromed M. i M. Nastaj Sp. P.
🇵🇱Lublin, Lubelskie, Poland
Parkinson's Disease and Movement Disorders Center of Boca Raton, Inc.
🇺🇸Boca Raton, Florida, United States
Dayanand Medical College & Hospital, Research & Development Centre
🇮🇳Ludhiāna, Punjab, India
Nizam's Institute of Medical Sciences
🇮🇳Panjagutta, Hyderabad, India
Lifepoint Multispeciality Hospital Pvt Ltd
🇮🇳Wakad, Pune, India
Bangur Institute of Neurosciences & Psychiatry (BINP)
🇮🇳Kolkata, India
NEURES, s.r.o.
🇸🇰Krompachy, Spiska Nova Ves, Slovakia
Medical Center Konzilium
🇸🇰Dubnica Nad Váhom, Trencin, Slovakia
Citi Neuro Centre
🇮🇳Hyderabad, Telangana, India
Institute of Neurosciences Kolkata
🇮🇳Kolkata, West Bengal, India
Krakowska Akademia Neurologii
🇵🇱Krakow, Malopolskie, Poland
Mazowiecki Szpital Brodnowski w Warszawie Sp. z o.o.
🇵🇱Warszawa, Poland
Hospital Universitari de Bellvitge (IDIBELL)
🇪🇸Barcelona, Spain
Plaza de Cruces, S/N
🇪🇸Barakaldo, Bilbao, Spain
Hospital Universitari General de Catalunya
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen de las Nieves
🇪🇸Granada, Spain
Policlínica Gipuzkoa
🇪🇸San Sebastian, San Sebastián, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario de la Princesa
🇪🇸Madrid, Spain
Hospital Quiron Salud
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Spain
Struthers Parkinson's Center -Park Nicollet
🇺🇸Golden Valley, Minnesota, United States
Weill Cornell Medicine Department of Neurology Parkinson's Disease and Movement Disorders Institute
🇺🇸New York, New York, United States
Neurology Specialists of Monmouth County, PA
🇺🇸West Long Branch, New Jersey, United States
Georgetown University Medical Center Department of Neurology, 7PHC
🇺🇸Washington, District of Columbia, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Renown Regional Medical Center
🇺🇸Reno, Nevada, United States
RCMed Oddział w Sochaczewie
🇵🇱Sochaczew, Mazowieckie, Poland
Advanced Neurology Epilepsy and Sleep Center
🇺🇸El Paso, Texas, United States
University of Kansas Medical Center (KUMC)
🇺🇸Kansas City, Kansas, United States
Evergreen Health
🇺🇸Kirkland, Washington, United States
Washington University (WUSTL) School of Medicine
🇺🇸Saint Louis, Missouri, United States
The Movement Disorder Clinic of Oklahoma
🇺🇸Tulsa, Oklahoma, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Central Texas Neurology Consultants (CTNC)
🇺🇸Round Rock, Texas, United States
Hospital Universitario Dr. Peset
🇪🇸Valencia, Spain
Nyiro Gyula Hospital
🇭🇺Budapest, Buapest, Hungary
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Xenoscience Inc. - 21st Century Neurology
🇺🇸Phoenix, Arizona, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Pacific Movement Disorders Center Pacific Neuroscience Institute Providence Saint John's Health Center
🇺🇸Santa Monica, California, United States
C.M. Silmedic Sp. z o.o.
🇵🇱Katowice, Slaskie, Poland
NZOZ Centrum Medyczne HCP
🇵🇱Poznań, Wielkopolskie, Poland
Dent Neurologic Institute - Amherst
🇺🇸Amherst, New York, United States
Valeomed Diagnosztikai Kozpont
🇭🇺Esztergom, Komárom-Esztergom, Hungary
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States