Recruiting

IPX203

Sponsor:

The Cleveland Clinic

Code:

NCT07138560

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

CREXONT ER

Study Details

Brief summary:

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

Study ID

NCT07138560

Start date

Jul 24, 2025

Status verified date

Aug, 2025

Completion date

May 15, 2027

Anticipated

Primary completion date

Dec 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

22 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Intervention Arm

The intervention arm will be patients converting to shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods and other parameters using the KinesiaU device, could reveal additional benefits of Crexont (IPX203) treatment.

Interventions

CREXONT ER

exploring shorter dose intervals of Crexont (IPX203) and allowing for higher dosing frequency, as practiced in real-world settings, combined with objective monitoring of on-time periods

Primary outcome measure

  • Primary Endpoint [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Saar Anis, MD

216 678-8896ANISS2@ccf.org

Mary Carmell Beukemann

216-372-2867beukemm@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

More Information

Sponsor

The Cleveland Clinic

Last update posted

Jun 23, 2026

Last verified

Aug, 2025

Keywords

  • Crexont
  • motor fluctuations

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-06-23.