Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease

Impax Laboratories

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00253084

IPX054-B04-07

Details and patient eligibility

About

The purpose of this study is to compare the clinical efficacy of IPX054 to immediate-release carbidopa-levodopa in subjects with 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: 12 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with idiopathic Parkinson's disease based on CAPIT (Core Assessment Program for Intracerebral Transplantations) criteria.
• Currently being treated with immediate-release carbidopa-levodopa with a stable dosing regimen over the past 4 weeks.

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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

12 participants in 2 patient groups

IPX054 - CD-LD IR

Other group

Description:

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.

Treatment:

Drug: CD-LD IR Placebo

Drug: IPX054 Placebo

Drug: IPX054 200 mg

Drug: CD-LD IR

CD-LD IR - IPX054

Other group

Description:

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.

Treatment:

Drug: CD-LD IR Placebo

Drug: IPX054 Placebo

Drug: IPX054 200 mg

Drug: CD-LD IR