Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease
NCT ID: NCT00253084
Last Updated: 2019-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2005-11-30
2007-12-31
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.
Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease
NCT00279825
Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
NCT00239564
A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Participants With Motor Fluctuations
NCT03670953
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.
* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
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
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
IPX054 - CD-LD IR
Subjects received IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks and then received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks.
IPX054 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX054 Placebo
Placebo to match IPX054 200 mg
CD-LD IR Placebo
Placebo to match CD-LD IR
CD-LD IR - IPX054
Subjects received IPX054 Placebo b.i.d and CD-LD IR q.i.d for 2 weeks and then IPX054 200 mg b.i.d and CD-LD IR Placebo q.i.d for 2 weeks.
IPX054 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX054 Placebo
Placebo to match IPX054 200 mg
CD-LD IR Placebo
Placebo to match CD-LD IR
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
IPX054 200 mg
IPX054 containing 50 mg carbidopa and 200 mg levodopa
CD-LD IR
CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
IPX054 Placebo
Placebo to match IPX054 200 mg
CD-LD IR Placebo
Placebo to match CD-LD IR
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
* Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.
Exclusion Criteria
* Allergic or non-responsive to previous carbidopa-levodopa therapy.
* Active or history of narrow-angle or wide-angle glaucoma.
* History of seizure or epilepsy, or is currently taking an anti-convulsant for treatment of seizure.
* Requires concomitant therapy with tricyclic antidepressants, MAO-B inhibitors, COMT inhibitors or anticholinergics.
* Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 6 months.
* Treatment with any dopaminergic blocking agent within the previous 6 months.
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.
Site 1
Chicago, Illinois, United States
Site 2
Charleston, South Carolina, United States
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.
IPX054-B04-07
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.