Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's Disease

Impax Laboratories

Status and phase: Completed; Phase 2

Conditions: Idiopathic Parkinson's Disease

Treatments: Drug: CD-LD IR Placebo; Drug: IPX054 200 mg Placebo; Drug: IPX054 250 mg Placebo; Drug: CD-LD CR; Drug: IPX054 250 mg; Drug: CD-LD CR Placebo; Drug: IPX054 200 mg; Drug: CD-LD IR

Study type: Interventional

Funder types: Industry

Identifiers

NCT00279825

IPX054-B05-01

Details and patient eligibility

About

The objective of this study is to compare the pharmacokinetics and pharmacodynamics of IPX054, carbidopa-levodopa immediate-release tablets, and carbidopa-levodopa controlled-release tablets in subjects with idiopathic Parkinson's disease.

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: 16 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with idiopathic Parkinson's disease.
• Currently being treated with immediate-release or controlled-release carbidopa-levodopa and not requiring more than 200 mg levodopa per dose.
• Must experience "wearing OFF" between doses of medication.

Exclusion criteria

• Diagnosed with atypical parkinsonism.
• 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 seizures.
• Treatment with any neuroleptic agent, including atypical neuroleptics, within the previous 12 months.
• Treatment with any dopaminergic blocking agent within the previous 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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16 participants in 4 patient groups

Sequence 1

Other group

Description:

Subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR.

Treatment:

Drug: IPX054 200 mg Placebo

Drug: CD-LD IR

Drug: IPX054 250 mg

Drug: CD-LD CR Placebo

Drug: IPX054 200 mg

Drug: IPX054 250 mg Placebo

Drug: CD-LD CR

Drug: CD-LD IR Placebo

Sequence 2

Other group

Description:

Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo.

Treatment:

Drug: IPX054 200 mg Placebo

Drug: CD-LD IR

Drug: IPX054 250 mg

Drug: CD-LD CR Placebo

Drug: IPX054 200 mg

Drug: IPX054 250 mg Placebo

Drug: CD-LD CR

Drug: CD-LD IR Placebo

Sequence 3

Other group

Description:

Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Third treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.

Treatment:

Drug: IPX054 200 mg Placebo

Drug: CD-LD IR

Drug: IPX054 250 mg

Drug: CD-LD CR Placebo

Drug: IPX054 200 mg

Drug: IPX054 250 mg Placebo

Drug: CD-LD CR

Drug: CD-LD IR Placebo

Sequence 4

Other group

Description:

Subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR. In Second treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR and 1 tablet of CD-LD CR Placebo. In Third treatment, subjects take 1 tablet of IPX054 200 mg Placebo, 1 tablet of IPX054 250 mg, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo. In Fourth treatment, subjects take 1 tablet of IPX054 200 mg, 1 tablet of IPX054 250 mg Placebo, 2 tablets of CD-LD IR Placebo and 1 tablet of CD-LD CR Placebo.

Treatment:

Drug: IPX054 200 mg Placebo

Drug: CD-LD IR

Drug: IPX054 250 mg

Drug: CD-LD CR Placebo

Drug: IPX054 200 mg

Drug: IPX054 250 mg Placebo

Drug: CD-LD CR

Drug: CD-LD IR Placebo