An Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Impax Laboratories, LLC
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Parkinsonian disability at Visits 1 and 5
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Undiagnosed skin lesion or history of melanoma
- •Epilepsy or history of seizures
Arms & Interventions
Experimental: carbidopa and levodopa
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.
Intervention: IPX054 100 mg (Drug)
Experimental: carbidopa and levodopa
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.
Intervention: IPX054 150 mg (Drug)
Experimental: carbidopa and levodopa
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.
Intervention: IPX054 200 mg (Drug)
Experimental: carbidopa and levodopa
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.
Intervention: IPX054 250 mg (Drug)
Experimental: carbidopa and levodopa
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.
Intervention: IPX054 300 mg (Drug)
Outcomes
Primary Outcomes
Parkinsonian disability at Visits 1 and 5
Time Frame: 36 Days
Secondary Outcomes
No secondary outcomes reported