OFF-Time - time when the medication is not working to its full potential and symptoms are not well controlled. This can be predictable such as wearing off between doses when symptoms return at the end of one dose before the next dose is taken; or this can be unpredictable where medication suddenly loses its effect or when a particular dose of medication does not take effect.
A Study to Assess the Efficacy and Safety of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients (Accordance)
Purpose: The purpose of this study is to determine whether the gastric retentive Accordion PillTM Carbidopa/Levodopa (AP-CD/LD) is more effective than the commercially available immediate release Carbidopa/Levodopa in reducing motor fluctuations such as "off time" in advanced Parkinson's Disease patients.
Study design: Randomized, double-blind, double-dummy
Study duration: The study will have 2 open label periods of 6 weeks each prior to the double blind period. In the open label periods all patients will be stabilized on the active comparator Sinemet® and on AP-CD/LD. The double blind active period will be 13 weeks long
Official title: Phase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's Patients
Men or women between 35 and 85 years of age, inclusive, at initial screening assessment.
Diagnosed with idiopathic Parkinson's disease.
Has a good response to levodopa in the opinion of the investigator, and is taking at least 4 doses of levodopa containing medication per day.
Total LD daily dose of 400 to 1300 mg in at least four divided doses, prior to initial screening assessment.
Able to complete a Hauser home diary and can tell the difference between "On and Off" time.
Participation in another drug clinical trial within 28 days prior to initial screening assessment.
Significant history of cardiac, pulmonary, hepatic or renal disease or other condition or any major complication/illness which, in the opinion of the investigator, contraindicates his/her participation.
Treatment with COMT inhibitors during the last 14 days prior to initial screening assessment.
Neurosurgical treatment for Parkinson's Disease.
History of alcohol or substance abuse within the past 2 years.
Unable to swallow large pills (e.g., large vitamin pills).
History of melanoma or suspicious current skin lesion.
Chronic wide-angle glaucoma.