An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
NCT ID: NCT01096186
Last Updated: 2019-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
617 participants
INTERVENTIONAL
2010-03-31
2011-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's Disease
NCT00880620
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
NCT00974974
Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease (PD) Participants With Motor Fluctuations
NCT03877510
A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
NCT01130493
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
NCT00869791
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* IPX066-B08-05 (A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease)
* IPX066-B08-11 (A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa - Levodopa)
* IPX066-B09-02 (A Study to Evaluate the Safety and Efficacy of IPX066 in Advanced Parkinson's Disease)
All participants will be given IPX066 for 9 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Open Label IPX066
Subjects received IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, or IPX066 245 mg for approximately 9 months. The dose and dosing frequency was determined by the investigator.
IPX066 95 mg
23.75 - 95 mg CD-LD capsules
IPX066 145 mg
36.25 - 145 mg CD-LD capsules
IPX066 195 mg
48.75 - 195 mg CD-LD capsules
IPX066 245 mg
61.25 - 245 mg CD-LD capsules
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IPX066 95 mg
23.75 - 95 mg CD-LD capsules
IPX066 145 mg
36.25 - 145 mg CD-LD capsules
IPX066 195 mg
48.75 - 195 mg CD-LD capsules
IPX066 245 mg
61.25 - 245 mg CD-LD capsules
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. In the opinion of the Investigator, the Parkinson's disease diagnosis is still valid and the subject remains eligible for LD therapy.
Exclusion Criteria
2. Anticipates functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) during study participation.
3. Received within 4 weeks prior to Baseline Visit or planning to take during study participation: nonselective monoamine oxidase (MAO) inhibitors (with the exception of rasagiline).
4. In the opinion of the Investigator, should not participate in the study.
30 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Impax Laboratories, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Impax Study Director
Role: STUDY_DIRECTOR
Impax Laboratories, LLC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Mohammed Ali Parkinson's Center
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Clinical Trials Inc.
Little Rock, Arkansas, United States
Coastal Neurological Medical Group
La Jolla, California, United States
Coordinated Clinical Research
La Jolla, California, United States
The Parkinson's Institute
Sunnyvale, California, United States
Collaborative NeuroScience Network, Inc.
Torrance, California, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Sunrise Clinical Research
Hollywood, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Charlotte Neurological Services Parkinson's Disease Treatment Center of S.W. Florida
Port Charlotte, Florida, United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States
University of South Florida, Parkinson's Disease and Movement Disorders Center
Tampa, Florida, United States
Medical College of Georgia, Movements Disorders Clinic
Augusta, Georgia, United States
Movement Disorder Center at Idaho Elks Rehabilitation Hospital
Boise, Idaho, United States
Northwestern University, Feinberg School of Medicine, Dept. of Neurology
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Quest Research Institute
Bingham Farms, Michigan, United States
Struthers Parkinson's Center
Golden Valley, Minnesota, United States
UMDNJ Robert Wood Johnson Medical Center, Department of Neurology
New Brunswick, New Jersey, United States
Albany Medical College, Parkinson's Disease and Movement Disorders Center
Albany, New York, United States
David L. Kreitzman, MD, P.C.
Commack, New York, United States
Columbia University Neurological Institute
New York, New York, United States
Institute for Human Performance
Syracuse, New York, United States
Duke University Medical Center Movement Disorders Center
Durham, North Carolina, United States
University Neurology, Inc.
Cincinnati, Ohio, United States
University of Toledo
Toledo, Ohio, United States
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
South Puget Sound Neurology
Tacoma, Washington, United States
Wisconsin Institute for Neurologic and Sleep Disorders
Milwaukee, Wisconsin, United States
London Health Sciences Centre, University Hospital
London, Ontario, Canada
Parkinson's & Neurodegenerative Disorder Clinic
Ottawa, Ontario, Canada
Ottawa Hospital Civic Site
Ottawa, Ontario, Canada
Quebec Memory & Motor Skills Disorders Clinic
Québec, Quebec, Canada
East Tallinn Central Hospital
Tallinn, , Estonia
West Tallinn Central Hospital,
Tallinn, , Estonia
Praxis für Neurologie und Psychiatrie
Westerstede, Lower Saxony, Germany
Neurozentrm - Praxis fur Neurologie und Psychiatrie
Berlin, , Germany
Neurologiepraxis
Berlin, , Germany
P.Stradina university hospital
Riga, , Latvia
Gailezers hospital
Riga, , Latvia
Kaunas Medical University Hospital
Kaunas, , Lithuania
Siauliai Regional Hospital
Šiauliai, , Lithuania
National Centre of Osteoporosis
Vilnius, , Lithuania
Vilnius University Emergency Hospital
Vilnius, , Lithuania
Vilnius University Hospital Santariskiu klinikos
Vilnius, , Lithuania
PALLMED Sp. z o.o.
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Krakowska Akademia Neurologii Sp. z o. o.
Krakow, Lesser Poland Voivodeship, Poland
Wojewódzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego, SPZOZ w Lublinie
Lublin, Lublin Voivodeship, Poland
Centrum Leczenia Chorób Cywilizacyjnych Sp. z o. o. S. K. A.
Warsaw, Masovian Voivodeship, Poland
Euromedis Sp. z o.o.
Szczecin, West Pomeranian Voivodeship, Poland
Gabinet Neurologiczny, Indywidualna Specjalistyczna Praktyka Lekarska
Mosina, Wielkopoloskie, Poland
Neuro-Care NZOZ
Katowice, , Poland
Clinical Rehabilitation Hospital Iasi, Neurology Department
Lasi, Romania, Romania
Psychiatry and Neurology Hospital Brasov, Neurology Department
Brasov, , Romania
Neomed Research
Brasov, , Romania
Colentina Clinical Hospital Bucharest, II Neurology Department
Bucharest, , Romania
CFR Clinical Hospital Constanta, Neurology Department
Constanța, , Romania
County Clinical Emergency Hospital Targu Mures, I Neurology Department
Târgu Mureş, , Romania
County Clinical Emergency Hospital Targu Mures, II Neurology Department
Târgu Mureş, , Romania
County Clinical Emergency Hospital Timisoara, Neurology Department
Timișoara, , Romania
Hospital General de Cataluña
Sant Cugat del Vallès, Barcelona, Spain
Clinica Ruber SA
Madrid, , Spain
Department of neurology and neurosurgery of Dnipropetrovsk State Medical Academy based on Dnipropetrovsk regional hospital named after Mechnikov
Dnipropetrovsk, , Ukraine
Department of Psychiatry and Medical Psychology of Donetsk National Medical University
Donetsk, , Ukraine
Department of Neurological Diseases and Medical Genetic of Donetsk National Medical University
Donetsk, , Ukraine
1st neurology department of Central Clinical Hospital of Ukrzaliznytsya
Kharkiv, , Ukraine
Department of Vascular Pathology of brain of Institute of neurology, psychiatry and narcology of AMS of Ukraine
Kharkiv, , Ukraine
Institute of Neurology, Psychiatry and Narcology of the AMS of Ukraine
Kharkiv, , Ukraine
Neurology department of Lviv regional clinical hospital
Lviv, , Ukraine
Odessa Regional Clinical Hospital, Dept. of Neurosurgery
Odesa, , Ukraine
Neurology department of Medical Dental Academy based on Poltava regional hospital
Poltava, , Ukraine
Vinnytsia Regional Psycho-Neurological Hospital
Vinnytsia, , Ukraine
Zaporizhzhya State Medical University based at Zaporizhzhya State Clinical Hospital #6
Zaporizhzhya, , Ukraine
Zaporozhye Regional Clinical Hospital
Zaporizhzhya, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IPX066-B09-03
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.