A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066
NCT ID: NCT01130493
Last Updated: 2019-10-29
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
110 participants
INTERVENTIONAL
2010-05-31
2012-01-31
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.
An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's Disease
NCT01096186
A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa
NCT00869791
A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).
NCT00974974
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
NCT03670953
Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study
NCT01411137
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IPX066-CLE-OLE
Dose conversion from CLE to IPX066, IPX066 (Part 1 Period 1), Open-label IPX066, CLE (Part 1 Period 2), OLE (Part 2)
IPX066
experimental product
CLE
active comparator
CLE-IPX066-OLE
Dose conversion from CLE to IPX066, CLE (Part 1 Period 1), Open-label IPX066, IPX066 (Part 1 Period 2), OLE (Part 2)
IPX066
experimental product
CLE
active comparator
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IPX066
experimental product
CLE
active comparator
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. At least 30 years old at the time of PD diagnosis.
3. Currently being treated with carbidopa/levodopa/entacapone (CLE) and on a stable regimen of conventional LD for at least 4 weeks and:
* Requiring a total daily levodopa (LD) dose of at least 400 mg
* Having a minimum dosing frequency of four times per day.
* Individual CD-LD or CLE doses that contain an LD dose which is a multiple of 50 mg.
4. Able to differentiate "on" state from "off" state.
5. Have predictable "off" periods.
6. Amantadine, anticholinergics, selective monoamine oxidase (MAO) type B inhibitors (e.g., selegiline, rasagiline) or dopamine agonists are allowed as long as the doses and regimens have been stable for at least 4 weeks prior to Screening and the therapy is intended to be constant throughout the course of the study.
7. Agrees to use a medically acceptable method of contraception throughout the study and for 1 month afterward.
Exclusion Criteria
2. Nonresponsive to LD therapy.
3. Prior functional neurosurgical treatment for PD (e.g., ablation or deep brain stimulation) or if such procedures are anticipated during study participation.
4. Received within 4 weeks of Screening or planning to take during participation in the clinical study: any controlled-release LD product, tolcapone, apomorphine, nonselective MAO inhibitors, or antipsychotics including neuroleptic agents for the purpose of treating psychosis or bipolar disorder.
5. Allergy or hypersensitivity to CD, LD, entacapone, riboflavin, Yellow Dye #5 (tartrazine), citrus fruit or grape juice.
6. History of or currently active psychosis.
7. Active or prior medical conditions such as peptic ulcers or prior surgical (e.g., bowel) procedures that would interfere with LD absorption.
8. Active or history of narrow-angle glaucoma.
9. History of malignant melanoma or a suspicious undiagnosed skin lesion.
10. History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias, upper gastrointestinal hemorrhage, or neuroleptic malignant syndrome or nontraumatic rhabdomyolysis.
11. Received any investigational medications during the 4 weeks prior to Screening.
12. Unable to swallow large pills (e.g., large vitamin pills).
13. Pregnant or breastfeeding.
14. Subjects who are unable to complete a symptom diary.
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.
Margolin Brain Institute
Fresno, California, United States
The Parkinson's Institute in Sunnyvale
Sunnyvale, California, United States
UM Movement Disorders Center
Miami, Florida, United States
Charlotte Neurological Services
Port Charlotte, Florida, United States
USF Parkinson's and Movement Disorders Center
Tampa, Florida, United States
Quest Research Institute
Bingham Farms, Michigan, United States
University Health Systems
Las Vegas, Nevada, United States
Parkinson's Disease and Movement Disorders Center of Long Island
Commack, New York, United States
Kingston Neurological Associates
Kingston, New York, United States
University Neurology, Inc
Cincinnati, Ohio, United States
Sentara Neurological Associates
Virginia Beach, Virginia, United States
Booth Gardner Parkinson's Care Center
Kirkland, Washington, United States
Hôpital Gabriel Montpied-Service de Neurologie A-
Clermont-Ferrand, , France
Service de neurologie-Hôpital de la Timone-
Marseille, , France
Praxis für Neurologie, Psychiatrie und Psychotherapie Achim
Achim, , Germany
Praxis Dres. Bitter/Schumann
Bochum, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Klinik für Neurologie, Stadtroda
Stadtroda, , Germany
RKU, Neurologische Klinik der Universität Ulm
Ulm, , Germany
Casa di Cura Villa Margherita
Arcugnano, , Italy
San Raffaele Cassino, San Raffaele Cassino,
Cassino, , Italy
Dipartimento di Oncologia e Neuroscienze, Università G. D'Annunzio
Chieti, , Italy
Ospedale della Misericordia
Grosseto, , Italy
IRCCS San Raffaele Pisana
Roma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Morgan JC, Dhall R, Rubens R, Khanna S, Gupta S. Dosing Patterns during Conversion to IPX066, Extended-Release Carbidopa-Levodopa (ER CD-LD), in Parkinson's Disease with Motor Fluctuations. Parkinsons Dis. 2018 Oct 22;2018:9763057. doi: 10.1155/2018/9763057. eCollection 2018.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IPX066-B09-06
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.