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BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease

Description

The purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.

Conditions

Parkinson Disease
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Related Conditions:

Parkinson Disease

Study Overview

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Study Details

Study overview

The purpose of this study is to evaluate the effect of IPX203 (Crexont®) - the newest extended-release levodopa formulation - on the duration and quality of good on time, using a wearable device to monitor symptoms. 'Good on time' refers to a period (minutes to hours) when a patient experiences optimal symptom control due to effective medication and has better overall functioning without troublesome dyskinesias. The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU.

BOOST-PD - Better On-time Observations of Motor Fluctuations Using Wearable Sensor Technology: A Naturalistic Study on IPX-203 for Parkinson's Disease

BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease

Condition
Parkinson Disease
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * - Participant is 40 years or older
  • * Diagnosed with idiopathic Parkinson's disease and is deemed to be levodopa responsive
  • * Baseline MDS-UPDRS score in OFF-state is \> 20
  • * Patient is being treated with a stable regimen of CD-LD for at least four weeks
  • * The minimum most frequent levodopa dosing is 100 mg if using IR CD-LD and 195mg if using Rytary; maximum levodopa dosing per day is 1200 mg if using IR CD-LD, 1000 mg if associated with a COMT inhibitor, and 2400 mg if using Rytary
  • * Participant can be on stable doses of any levodopa adjunctive medications and/or psychotropic medications for at least 30 days
  • * Participant experiences off time estimated at 2 hours or more per day; participant can comply with the wearable kinematic device.
  • * - Participants with severe dyskinesia as defined by a score of 4 on Question 4.1 (time spent with dyskinesia) of UPDRS IV
  • * Currently on device-aided therapies for advanced PD
  • * Using controlled-release CD-LD apart from a single daily bedtime dose
  • * Using "on demand" therapy unless willing to stop it during the study period
  • * Have a diagnosis hypothesis of dopamine dysregulation syndrome or evidence of significant levodopa-related complications including orthostatic hypotension or psychosis
  • * History of dementia or MOCA score lower than 23
  • * Significant medical history might interfere significantly with study participation
  • * Being enrolled in other clinical trials involving active medication interventions.

Ages Eligible for Study

40 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Hubert Fernandez, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2027-05-15