An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients

Osmotica Pharmaceutical US LLC9 sites in 1 country78 target enrollmentNovember 2007

ConditionsParkinson's Disease

Interventionslevodopa-carbidopa

Drugslevodopa-carbidopa

Overview

Phase: Phase 2
Intervention: levodopa-carbidopa
Conditions: Parkinson's Disease
Sponsor: Osmotica Pharmaceutical US LLC
Enrollment: 78
Locations: 9
Primary Endpoint: Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Determine if a novel levodopa/carbidopa formulation results in a better clinical response on Parkinson's Disease patients compared to the reference formulation of levodopa/carbidopa in terms of motor complications, onset of action and response duration.

Detailed Description

Primary objective is to demonstrate a better clinical response profile of novel levodopa/carbidopa formulation vs. the reference formulation of levodopa/carbidopa in patients with Parkinson's Disease as judged by motor performance and to describe pharmacokinetic profile for the novel formulation compared to the reference.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

December 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Osmotica Pharmaceutical US LLC

Eligibility Criteria

Inclusion Criteria

•Clinical diagnostic of Parkinson's Disease, with a Hoehn and Yahr Staging within 2-4, and L-Dopa therapy complications
•at least 2years of L-Dopa therapy
•Patients with the ability to differentiate between "ON" and "OFF" periods
•Patients who have been receiving stable doses of L-Dopa between 600 and 1600 mg/day, for at least 2 months prior to the screening visit using a dosing regimen not higher that 5 times a day, and not expected in the investigator's opinion to need any dose modifications over the duration of the study
•Patients presenting a score of at least 2 in the UPDRS IVa, item 32 and/or a score of at least 2 in the UPDRS IVb, item 39, at screening and randomization visits based on clinical records for the first visit and daily diary cards at randomization time.
•Willing and able to understand and sign Informed Consent form

Exclusion Criteria

•Patients with a diagnosis of any known secondary Parkinsonian syndrome, (vascular, toxin or drug-induced, metabolic or infectious, etc) or other neurodegenerative disorder with parkinsonism (Progressive Supranuclear Palsy, Corticobasal Degeneration, Multiple System Atrophy, etc).
•Patients receiving other concomitant anti-Parkinsonian pharmacological therapies affecting L-dopa or dopamine metabolisom (COMT inhibitors or MAO inhibitors)
•Subjects who have undergone prior functional neurosurgical treatment for PD (ablation or Deep Brain Stimulation).
•Patient with a L-dopa dosage regimen greater than 5 times a day which is not able to be adapted to a q.i.d. regimen.
•Patients having received L-dopa / Decarboxylase inhibitors therapy for less than 2 years.
•Patients needing nightly doses of L-dopa / Decarboxylase inhibitors apart from the four daily doses.
•Any medical condition or past medical history that, in the investigator's judgment, would increase the risk of exposure to L-dopa / Carbidopa or interfere with the evaluation of the study objectives.
•Patients with unstable or clinically significant known medical illness; such as cardiac, pulmonary, kidney, hepatic and/or gastrointestinal disease that would, in the investigator's judgment, interfere with the safe course of the study.
•Cognitive impaired patients, as determined by a score of lesser than 26 on the Mini-Mental Score Status Examination. (MMSE \< 26).
•Alcohol or illegal drugs abuse.

Arms & Interventions

A

Intervention: levodopa-carbidopa

B

Intervention: levodopa-carbidopa

Outcomes

Primary Outcomes

Evidence of a novel levodopa/carbidopa formulation providing a better clinical profile than reference levodopa/carbidopa formulation using Unified Parkinson's Disease Rating Scale (UPDRS III) and patient's diary cards

Time Frame: every half hour for the first 8 hours after dosing

Secondary Outcomes

Other measurements to be used for demonstrating clinical profile is UPDRS II and IV, Clinical Global Impression Scale (CGI)/Patient's Global Improvement Scale (PGI), and the Abnormal Involuntary Movement Scale (AIMS)(over the course of the study)