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

Impax Laboratories

Status and phase: Completed; Phase 2; Phase 1

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: IPX054 300 mg; Drug: IPX054 200 mg; Drug: IPX054 150 mg; Drug: IPX054 100 mg; Drug: IPX054 250 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00239564

IPX054-B04-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Experimental: carbidopa and levodopa

Experimental group

Description:

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.

Treatment:

Drug: IPX054 250 mg

Drug: IPX054 100 mg

Drug: IPX054 150 mg

Drug: IPX054 200 mg

Drug: IPX054 300 mg