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RecruitingPhase 4

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The change in the duration and quality of on-time will be measured by a wearable device placed on your wrist called KinesiaU."
  • "This will be done with the assistance of a wearable device to obtain objective data."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how IPX203 (Crexont), a long-acting levodopa medicine, affects “good on time” in people with Parkinson’s disease. This is time when medicine controls symptoms well without unwanted movements that cause problems. Adults age 40 or older will use a wrist device called KinesiaU to track symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 40 or older.
  • You have idiopathic Parkinson’s disease, meaning its cause is unknown, and levodopa helps your symptoms.
  • Your starting MDS-UPDRS score, a measure of Parkinson’s symptoms, is above 20 when your medicine is not working well.
  • You have taken a steady dose schedule of carbidopa-levodopa (CD-LD) for at least 4 weeks.
  • Your most common levodopa dose is at least 100 mg for immediate-release CD-LD or 195 mg for Rytary.
  • Your total daily levodopa dose is no more than 1,200 mg for immediate-release CD-LD, 1,000 mg if also taking a COMT inhibitor (a medicine that helps levodopa work longer), or 2,400 mg for Rytary.
  • If you take other medicines to help levodopa work or medicines for mental health, their doses have been steady for at least 30 days.
  • You have at least 2 hours a day when your medicine does not control symptoms well, and you can use the wrist device as directed.

Who can't join

  • You have severe dyskinesia (unwanted movements), with a score of 4 on UPDRS Part IV, question 4.1, which measures time spent with these movements.
  • You currently use a device-based treatment for advanced Parkinson’s disease.
  • You take controlled-release CD-LD, unless it is only one daily dose at bedtime.
  • You use an “on demand” medicine for symptoms and are not willing to stop it during the study.
  • Doctors suspect dopamine dysregulation syndrome (a problem with overusing Parkinson’s medicine), or you have major levodopa-related problems, such as blood pressure drops when standing or trouble knowing what is real.
  • You have a history of dementia (serious memory and thinking problems), or your MoCA memory and thinking test score is below 23.
  • You have a major medical history that could greatly affect your ability to take part.
  • You are in another clinical trial that involves active medicine treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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. Exclusion Criteria: * \- 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.

Study sites (1)

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