IPX203 for Parkinson's Disease

(BOOST-PD Trial)

Overseen By Mary Carmell Beukemann

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: The Cleveland Clinic

Must be taking: Levodopa

Must not be taking: Controlled-release CD-LD

Disqualifiers: Severe dyskinesia, Dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new extended-release medication, IPX203 (Crexont®), to evaluate its effectiveness in increasing "good on time" for people with Parkinson’s disease. "Good on time" refers to periods when symptoms are well-controlled, allowing patients to go about their day without bothersome movements. The study uses a wrist device to measure the duration and effectiveness of the medication. Individuals diagnosed with Parkinson’s, who are already taking levodopa, and experience at least 2 hours a day of poor symptom control might be suitable for this trial. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you need to be on a stable dose of your current Parkinson's medications for at least 30 days before joining. If you use 'on demand' therapy, you must be willing to stop it during the study.

What is the safety track record for IPX203?

Research has shown that IPX203, also known as Crexont®, is generally safe for people with Parkinson's disease. One study found that taking IPX203 about three times a day for nine months was effective and usually safe. Another study demonstrated that it could help improve movement and increase "good on time," when symptoms are well-controlled. Although the treatment is considered safe, all medicines can have side effects, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about IPX203 for Parkinson's disease because it offers a potentially more flexible and effective dosing regimen compared to current treatments. Unlike standard medications like Levodopa that often require strict dosing schedules, IPX203 allows for shorter dose intervals and higher dosing frequency, which could lead to more consistent symptom control. Plus, with the integration of the KinesiaU device, patients and doctors can objectively monitor "on-time" periods and other important parameters, potentially enhancing the overall treatment experience and outcomes. This approach aims to provide a more personalized and responsive treatment for those living with Parkinson's disease.

What is the effectiveness track record for IPX203 in treating Parkinson's Disease?

Research has shown that IPX203, also known as Crexont, may help treat Parkinson's disease. One study found that taking IPX203 about three times a day for nine months helped keep symptoms under control and was generally safe. Another study suggested that IPX203 can reduce "Off" time, when medication isn't working well, and increase "Good On" time, meaning patients have better symptom control for longer. Additionally, IPX203 has improved sleep quality, which is important for managing overall symptoms. Compared to immediate-release carbidopa-levodopa, IPX203 may provide more consistent control of movement problems, which are common in Parkinson's disease. Participants in this trial will be in an intervention arm where they convert to shorter dose intervals of Crexont (IPX203) and allow for higher dosing frequency, combined with objective monitoring using the KinesiaU device. ^{1 3 4 5 6}

Who Is on the Research Team?

Hubert Fernandez, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are looking to improve their 'good on time'—when symptoms are well-controlled by medication. Details about specific inclusion and exclusion criteria were not provided, so interested participants should inquire further.

Inclusion Criteria

I am 40 years old or older.

Baseline MDS-UPDRS score in OFF-state is > 20

Participant experiences off time estimated at 2 hours or more per day; participant can comply with the wearable kinematic device.

Exclusion Criteria

History of dementia or MOCA score lower than 23

Significant medical history might interfere significantly with study participation

I am willing to stop my 'on demand' therapy for the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IPX203 (Crexont®) with tailored dose adjustments, monitored using the KinesiaU device

8 weeks

Regular monitoring using wearable device

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IPX-203

Trial Overview The study tests IPX203 (Crexont®), a new extended-release levodopa formulation, to see if it extends the duration and quality of symptom control in Parkinson's patients. Participants will wear a KinesiaU device on their wrist to monitor changes.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Amneal Pharmaceuticals, LLC

Industry Sponsor

Trials

13

Recruited

28,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10922967/

Safety and Efficacy of IPX203 in Parkinson Disease Trial results suggest that treatment with IPX203 given an average of 3 times a day for 9 months provides maintained efficacy and is generally safe and well ...

2. investors.amneal.com investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-New-Data-from-Phase-3-Study-Showing-Significant-Improvements-in-Sleep-Quality-with-CREXONT-Carbidopa-and-Levodopa-Extended-Release-Capsules-in-Parkinsons-Disease/default.aspx

Amneal Announces New Data from Phase 3 Study Showing ... The new Phase 3 data analysis shows CREXONT's ability to significantly improve sleep, in addition to its effects on daytime PD symptoms.

3. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2808496

IPX203 vs Immediate-Release Carbidopa-Levodopa for ... The results of this study suggest that IPX203 vs immediate-release carbidopa-levodopa may be useful in patients with Parkinson disease and motor fluctuations.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6791502/

Pharmacodynamics, Efficacy, and Safety of IPX203 in ... IPX203 demonstrated a sustained effect to reduce Off time and improve Good On time in patients with PD and motor fluctuations. Both treatments were well ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03670953

NCT03670953 | A Study to Evaluate the Safety and ... A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor ...

6. neurology.org neurology.org/doi/abs/10.1212/WNL.0000000000208983

Efficacy and Safety of IPX203 in Parkinson's Patients IPX203 shows a significant potential in improving motor functions, reducing “off” time while increasing “good on” time.