Smartwatch study aims to Fine-Tune Parkinson's medication timing

NCT ID NCT07138560

Disease control Sponsor: The Cleveland Clinic Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study investigates whether a wrist-worn sensor (KinesiaU) can accurately measure how long people with Parkinson's disease experience 'good on-time' — periods when medication works well and symptoms are controlled without troublesome movements. Researchers are testing IPX-203 (Crexont), an extended-release levodopa, in 22 adults aged 40 and older with Parkinson's. The goal is to see if the sensor can help doctors adjust dosing schedules for better symptom management in daily life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: IPX-203 (Crexont ER, an extended-release levodopa formulation)
What this could lead to: If successful, this study could show that wearable sensors help doctors fine-tune Parkinson's medication dosing for better symptom control throughout the day.
What could go wrong: This is a small, early-phase study with only 22 participants, so results may not apply to everyone. The wearable device may not capture all symptom changes accurately.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 22 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Smartwatch study aims to Fine-Tune Parkinson's medication timing

What the study statuses mean