A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-Levodopa

Impax Laboratories

Status and phase: Completed; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: IR CD-LD; Drug: IPX066

Study type: Interventional

Funder types: Industry

Identifiers

NCT00869791

IPX066-B08-11

Details and patient eligibility

About

This study evaluated the pharmacokinetics, motor effects, and assessed the safety of IPX066 compared with an immediate-release cabridopa-levodopa formulation in subjects with advanced Parkinson's disease.

Full description

This was a randomized, multicenter, open-label, single and multiple oral dose, two-treatment, two-period, crossover study in LD-experienced subjects with Parkinson's disease (PD). Subjects received 7 days of one treatment (IPX066 or IR CD-LD) followed by an approximate 7-day washout period followed by another 7 days of the other treatment (IR CD-LD or IPX066). During the approximate 7-day washout period, subjects took their prestudy CD-LD regimen. Pharmacokinetic and efficacy/pharmacodynamic measurements were done on Days 1 and 8. Safety measures (electrocardiograms [ECGs], clinical laboratory tests, vital signs, adverse events [AEs], and concomitant medications) were evaluated over the course of the study.

Enrollment: 27 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female diagnosed with idiopathic PD, without any known cause for Parkinsonism.
2. If female and of childbearing potential, subject should be abstinent or continuing to practice and willing to continue throughout the study with appropriate contraceptives (defined as Nova ring, oral, injected, transdermal patch, implanted, or barrier). The subject must agree to take every precaution to ensure that pregnancy will not occur during the study.
3. At least 30 years old at the time of diagnosis of PD.
4. Mini Mental State Examination (MMSE) ≥ 26 at Screening Visit.
5. A responder to LD and currently being chronically treated with stable dosage of commercially available standard, orally disintegrating, or controlled-release CD LD for at least 1 month.
6. Must have predictable fluctuations between "on" and "off" states.
7. Hoehn and Yahr Stage I-IV when "on".
8. Able to provide informed consent and willing to sign Health Insurance Portability and Accountability Act (HIPAA) authorization.
9. Able and willing to comply with the protocol, including availability for all scheduled study visits and blood sample collections.

Exclusion criteria

1. Pregnant or breastfeeding.
2. Diagnosed with atypical parkinsonism.
3. History, physical findings or laboratory results suggesting a diagnosis other than PD.
4. Allergic or nonresponsive to previous CD-LD therapy.
5. Any medical (e.g., liver or kidney impairment, peptic ulcer) or condition/history that, in the Investigator's opinion, may jeopardize the subject's safety.
6. Exposure to any investigational agent within 30 days prior to Visit 1.
7. Donated blood or plasma within 28 days.
8. Had prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Sequence 1

Other group

Description:

Treatment Period 1: IPX066 - 7 days; Washout Period - 7 days; Treatment Period 2: IR CD-LD- 7 days

Treatment:

Drug: IPX066

Drug: IR CD-LD

Sequence 2

Other group

Description:

Treatment Period 1: IR CD-LD - 7 days; Washout period - 7 days; Treatment Period 2: IPX066- 7 days

Treatment:

Drug: IPX066

Drug: IR CD-LD