Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The objective is to compare the pharmacokinetics and pharmacodynamics of IPX054 and carbidopa-levodopa immediate-release tablets in subjects with idiopathic Parkinson's disease who are currently being treated with a stable regimen of carbidopa-levodopa immediate-release tablets.

Detailed Description
-----------------
IPX054 contains two different drugs called levodopa and carbidopa in one tablet. 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.

Official Title
-----------------
An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease

Conditions
-----------------
Idiopathic Parkinson's Disease

Intervention / Treatment
-----------------
* Drug: IPX054 100 mg
* Drug: IPX054 150 mg
* Drug: IPX054 200 mg
* Drug: IPX054 250 mg
* Drug: IPX054 300 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of idiopathic Parkinson's disease Currently being treated with a stable dosage regimen of immediate-release carbidopa-levodopa for at least 3 months. Must experience at least 3 episodes of wearing OFF symptoms and an average of at least 2 hours of OFF time per day. Exclusion Criteria: Diagnosed with atypical parkinsonism Prior surgical interventions for Parkinson's disease Glaucoma Undiagnosed skin lesion or history of melanoma Epilepsy or history of seizures

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: carbidopa and levodopa<br>Subjects receive IPX054 100 mg, IPX054 150 mg, IPX054 200 mg, IPX054 250 mg, or IPX054 300 mg to achieve optimum dosage and dosing frequency as directed by the Investigator for 5 weeks. | Drug: IPX054 100 mg<br>* IPX054 containing 25 mg carbidopa and 100 mg levodopa<br>* Other names: CD-LD ER 100 mg;Drug: IPX054 150 mg<br>* IPX054 containing 37.5 mg carbidopa and 150 mg levodopa<br>* Other names: CD-LD ER 150 mg;Drug: IPX054 200 mg<br>* CD-LD CR containing 50 mg carbidopa and 200 mg levodopa<br>* Other names: CD-LD ER 200 mg;Drug: IPX054 250 mg<br>* CD-LD CR containing 62.5 mg carbidopa and 250 mg levodopa<br>* Other names: CD-LD ER 250 mg;Drug: IPX054 300 mg<br>* CD-LD CR containing 75 mg carbidopa and 300 mg levodopa<br>* Other names: CD-LD ER 300 mg;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parkinsonian disability at Visits 1 and 5 |  | 36 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IPX054, Parkinson disease, Levodopa