---
title: Increase daily steady on time
nct_id: NCT07138560
phase: PHASE4
status: RECRUITING
sponsor: The Cleveland Clinic
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07138560"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07138560"
last_fetched: "2026-05-10T14:08:14.716Z"
source: "Parkinson's Pathways (curated)"
---
# Increase daily steady on time

**Goal (in five words):** Increase daily steady on time

**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

**Trial ID:** [NCT07138560](https://clinicaltrials.gov/study/NCT07138560)

## Key Facts

- **Phase:** PHASE4
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** The Cleveland Clinic
- **Target Enrollment:** 22 participants
- **Start Date:** 2025-07-24
- **Completion Date:** 2026-05-15
- **Conditions:** Parkinson Disease
- **Interventions:** CREXONT ER
- **Intervention Types:** DRUG

## Summary For Families

The goal is to find out whether CREXONT ER (IPX-203), an extended-release carbidopa‑levodopa, can give longer, steadier on time and reduce daily motor fluctuations for people with Parkinson's in their usual lives. CREXONT ER slowly releases levodopa to keep brain dopamine levels more stable than immediate-release pills, and the study uses a wearable motion sensor to track real-world on/off periods while people remain on compatible Parkinson's medications. The study is looking for adults 40 and older with idiopathic, levodopa-responsive Parkinson's who have at least 2 hours of off time per day and are on a stable carbidopa‑levodopa regimen; it excludes those with severe dyskinesia, device-based therapies, significant cognitive impairment, major levodopa complications, or current participation in other active drug trials.

## Eligibility

- **Minimum age:** 40 Years
- **Sex:** ALL

### Full 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.
```

## Locations (1)

- Cleveland Clinic, Cleveland, Ohio, United States _(41.4995, -81.6954)_

## Central Contacts

- Saar Anis, MD — (CONTACT) — 216 678-8896 — ANISS2@ccf.org
- Mary Carmell Beukemann — (CONTACT) — 216-372-2867 — beukemm@ccf.org

---

*Canonical: https://parkinsonspathways.com/trial/NCT07138560*  
*HTML version: https://parkinsonspathways.com/trial/NCT07138560*  
*Source data: https://clinicaltrials.gov/study/NCT07138560*