RECRUITING

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

Conditions

Parkinson Disease Crexont motor fluctuations

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-07-24

Study Completion:2027-05-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07138560

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.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Saar Anis, MD

CONTACT

216 678-8896

ANISS2@ccf.org

Mary Carmell Beukemann

CONTACT

216-372-2867

beukemm@ccf.org

Principal Investigator

Hubert Fernandez, MD

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Hubert Fernandez, MD, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-24

Study Completion Date2027-05-15

Study Record Updates

Study Start Date2025-07-24

Study Completion Date2027-05-15

Terms related to this study

Keywords Provided by Researchers

Crexont
motor fluctuations

Additional Relevant MeSH Terms

Parkinson Disease