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

NCT07138560 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 25-0704322795
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Crexont; motor fluctuations

Outcome Measures

Primary Outcomes (1)

• Primary Endpoint

  Mean change in the average duration of good on-time from baseline to end of study

  8 weeks

Secondary Outcomes (5)

• Secondary Endpoint

  8 weeks

• Secondary Endpoint

  8 weeks

• Secondary Endpoint

  8 weeks

• Secondary Endpoint

  8 weeks

• Secondary Endpoint

  8 weeks

Other Outcomes (5)

• Exploratory Endpoints

  8 weeks

• Exploratory Endpoint

  8 weeks

• Exploratory Endpoint

  8 weeks

Study Arms (1)

Intervention Arm

OTHER

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.

Drug: CREXONT ER

Interventions

CREXONT ER DRUG

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

Also known as: IPX203

Intervention Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Amneal Pharmaceuticals, LLC: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Related Publications (3)

• Modi NB, Mittur A, Dinh P, Rubens R, Gupta S. Pharmacodynamics, Efficacy, and Safety of IPX203 in Parkinson Disease Patients With Motor Fluctuations. Clin Neuropharmacol. 2019 Sep/Oct;42(5):149-156. doi: 10.1097/WNF.0000000000000354.

  PMID: 31306216 BACKGROUND

• Hauser RA, Espay AJ, Ellenbogen AL, Fernandez HH, Isaacson SH, LeWitt PA, Ondo WG, Pahwa R, Schwarz J, Stocchi F, Zeitlin L, Banisadr G, Fisher S, Visser H, D'Souza R. IPX203 vs Immediate-Release Carbidopa-Levodopa for the Treatment of Motor Fluctuations in Parkinson Disease: The RISE-PD Randomized Clinical Trial. JAMA Neurol. 2023 Oct 1;80(10):1062-1069. doi: 10.1001/jamaneurol.2023.2679.

  PMID: 37578800 BACKGROUND

• Hauser RA, Fernandez HH, Jimenez-Shahed J, Allard S, Banisadr G, Fisher S, D'Souza R. Duration of "Good On" time per dose: Immediate-release carbidopa-levodopa vs. extended-release carbidopa-levodopa (IPX203, CREXONT(R)). Parkinsonism Relat Disord. 2025 Feb;131:107239. doi: 10.1016/j.parkreldis.2024.107239. Epub 2024 Dec 15.

  PMID: 39733558 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Hubert Fernandez, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Saar Anis, MD

CONTACT

216 678-8896; ANISS2@ccf.org

Mary Carmell Beukemann

CONTACT

216-372-2867; beukemm@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Center Director

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: August 24, 2025
• Study Start: July 24, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)