Phase 4 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People diagnosed with Parkinson's disease according to a standard set of established diagnostic guidelines, who are currently on a stable dose of oral carbidopa-levodopa (a common Parkinson's medication).
• People whose Parkinson's motor symptoms score at least 20 points on a standard rating scale when measured in an "Off" state (when medication is not working well) at the screening visit.
• People who have predictable "Off" periods (times when medication wears off and symptoms worsen), rated at a specific level on a standard Parkinson's scale at screening.
• People who, in the 4 weeks before screening, experienced daily predictable "wearing-off" episodes and an average of at least 2.5 hours per day of "Off" time while awake.
• People who can reliably tell the difference between when their medication is working ("On") and when it is not ("Off"), confirmed through a 4-hour training session with trial staff, achieving at least 75% agreement with a trained rater (a second training session may be offered if the first is not passed).
• People whose 3-day Parkinson's diary records, completed before the first study visit, confirm they are completing diaries properly and show an average of at least 2.5 hours of "Off" time per day while awake, with at least 1.5 hours of "Off" time on each of the 3 diary days.
• People who respond to carbidopa-levodopa therapy and have been on a stable oral dose for at least 4 weeks before the first study visit, meeting specific daily dose and dosing frequency requirements depending on which form of the medication is taken (confirm specific dose requirements with trial site).
• People who are willing and able to give written consent before any study procedures begin.
• People who are able and willing to follow the study requirements, including completing diaries and questionnaires and attending all visits and phone calls.
• People who have taken part in earlier studies of CREXONT (the study medication) are also eligible to join.

Who may not be able to join:

• People whom the treating investigator believes should not participate based on the prescribing information for CREXONT.
• People who have previously had brain surgery for Parkinson's disease (such as deep brain stimulation or surgical ablation), or who have such a procedure planned before Day 42 of the study.
• People who, in the 4 weeks before the first study visit, received certain medications including: controlled-release carbidopa-levodopa (other than a single bedtime dose), Duopa (a gel form of carbidopa-levodopa), a non-selective MAO inhibitor, or rescue medications used to treat "Off" episodes such as apomorphine or inhaled levodopa (Inbrija®).
• People who have taken any experimental/investigational drugs within 30 days (or longer, depending on the drug) before the first study visit.
• People whom the treating investigator believes should not participate for any clinical reason, including not being able to sufficiently understand the terms needed to complete the Parkinson's diary or other study questionnaires.
• Employees or family members of the investigator, study site staff, or the study sponsor.

Important: Always verify eligibility with the trial site directly before applying.