CREXONT ER for Parkinson's Disease

Recruiting at 27 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Impax Laboratories, LLC

Must be taking: CD-LD

Must not be taking: Nonselective MAOI, Apomorphine

Disqualifiers: Prior neurosurgical treatment, 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: 6 weeks

220 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness and safety of CREXONT, a medication used in real-world conditions to aid those with Parkinson's disease. The researchers aim to find the right balance for each participant by adjusting doses to improve daily living with fewer "off" periods, when symptoms like tremors and stiffness worsen. The trial seeks individuals who have consistently used oral Parkinson's medication, experience daily episodes of worsening symptoms, and can accurately track their on and off periods. As a Phase 4 trial, CREXONT is already FDA-approved and proven effective, and this research helps understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable regimen of oral CD-LD (a medication for Parkinson's) for at least 4 weeks before starting. Some medications, like certain CR CD-LD doses, Duopa, nonselective MAOIs, and rescue medications for 'off' episodes, must be stopped at least 4 weeks before the trial begins.

What is the safety track record for CREXONT?

Research has shown that CREXONT ER, a long-lasting form of carbidopa and levodopa, is generally safe for people with Parkinson's disease. Studies comparing it to the regular versions of these drugs have demonstrated a good safety record for CREXONT ER.

The safety data comes from 589 patients who used CREXONT ER for up to 76 weeks, with an average use of about 35 weeks, indicating its safety over time.

Carbidopa and levodopa are common treatments for Parkinson's, helping manage symptoms like muscle stiffness and tremors. CREXONT ER offers a new way to take these medications, providing more stable and longer-lasting effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard options for Parkinson's disease, which typically involve immediate-release formulations of carbidopa/levodopa, CREXONT ER offers an extended-release formulation. This means it provides a more consistent and prolonged delivery of the medication, potentially smoothing out the fluctuations in symptoms that patients experience with current treatments. Researchers are excited about CREXONT ER because it could offer improved symptom control and enhance overall quality of life for people living with Parkinson’s.

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

Research has shown that CREXONT ER, the treatment under study in this trial, effectively treats symptoms of Parkinson's disease. One study found that CREXONT increases "Good On" time, when symptoms are well-controlled, by 1.74 hours compared to immediate-release versions. It also reduces the number of doses needed each day. Another study highlighted that CREXONT significantly improves sleep quality for people with Parkinson’s. The main ingredients in CREXONT, Carbidopa and Levodopa, are known as the most effective oral treatment for managing movement symptoms in Parkinson's disease. CREXONT ER is approved for use, confirming its effectiveness and safety in everyday use. ^{6 7 8 9 10}

Who Is on the Research Team?

Hester Visser, MD

Principal Investigator

Amneal Pharmaceuticals, LLC

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's Disease who have stable treatment regimens of oral Carbidopa-Levodopa, can tell the difference between 'On' and 'Off' states, and experience at least 2.5 hours per day of 'Off' time. They must not have had neurosurgical treatments for PD or plan to before Day 42 of the study.

Inclusion Criteria

At Screening, the participant is able to differentiate 'On' state from 'Off' state as determined by at least 75% concordance with a trained rater in 'On/Off' ratings for 8 ratings over a 4-hour training period

Participants with a score of at least 20 units at Screening on the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III total score in the 'Off' state

Participants with predictable 'Off' periods at Screening defined by a score of 1 or 2 (Complexity of Motor Fluctuations) of the MDS-UPDRS Part IV B (Motor Fluctuations)

Exclusion Criteria

Employees or family members of the investigator, study site staff, or Sponsor

Participant who, in the opinion of the clinical investigator, should not participate in the study based on the CREXONT Prescribing Information

Participant who, in the opinion of the clinical investigator, should not participate in the study based on clinical assessment or any other reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CREXONT extended release capsules, with dosing optimized based on FDA guidelines

6 weeks

Regular visits as per dosing optimization needs

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CREXONT

Trial Overview The trial tests CREXONT Extended-Release Capsules to see how effective and safe they are in real-world conditions for those with Parkinson's Disease. Participants will be monitored through diaries, questionnaires, visits, and calls.

How Is the Trial Designed?

Group I: CREXONT ER Experimental Treatment 1 Intervention

Participants will receive CREXONT extended release (ER) capsules, orally, as guided by the Food and Drug Administration (FDA) approved prescribing Information. CREXONT ER capsules will contain Carbidopa (CD)/Levodopa (LD) 35.0 milligrams (mg)/140 mg and/or CD/LD 52.5 mg/210.0 mg and/or CD/LD 70.0 mg/280 mg and/or CD/LD 87.5 mg/350 mg. The initial CREXONT dosing regimen will be based on the FDA approved CREXONT prescribing information for dose conversion from prior oral CD-LD medications to CREXCONT. Thereafter the dosing regimen can be optimized as appropriate for the condition of each participant and guided by the FDA approved CREXONT prescribing information, in order to achieve the optimal balance of efficacy and tolerability for each participant.

Who Is Running the Clinical Trial?

Impax Laboratories, LLC

Lead Sponsor

Trials

21

Recruited

4,700+

Amneal Pharmaceuticals, LLC

Industry Sponsor

Trials

13

Recruited

28,500+

Published Research Related to This Trial

A meta-analysis of three randomized controlled trials with 1021 patients found that the once-daily extended-release (ER) formulation of pramipexole has similar adverse event rates compared to the standard immediate-release (IR) formulation in patients with Parkinson's disease.

Common adverse events such as nausea, somnolence, dizziness, and dyskinesia showed no significant differences between the two formulations, indicating that both options are similarly safe for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease. Shen, Z., Kong, D.[2022]

Pramipexole extended release (ER) administered once daily is effective in treating early Parkinson's disease, showing a significant improvement in motor and daily living activities compared to placebo, with a notable reduction in Unified Parkinson Disease Rating Scale (UPDRS) scores.

The safety profile of pramipexole ER is comparable to that of pramipexole immediate release (IR), although it has a higher incidence of side effects like somnolence, nausea, constipation, and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease. Hauser, RA., Schapira, AH., Rascol, O., et al.[2022]

Pramipexole (PPX) was evaluated for its efficacy and safety as an additional treatment for advanced Parkinson's disease in patients already taking levodopa, compared to a placebo.

The study also included a bromocriptine (BR) group to assess whether PPX is at least as effective as BR, which is considered a standard treatment for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind study of pramipexole with placebo and bromocriptine in advanced Parkinson's disease. Mizuno, Y., Yanagisawa, N., Kuno, S., et al.[2018]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351126/

Efficacy and Safety of Twelve Anti‐Dyskinetic Drugs in ... Amantadine ER improved dyskinesia significantly versus amantadine IR. Both formulations of amantadine were superior as OFF time‐reducing agents ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1353802024012513

Duration of “Good On” time per dose: Immediate-release ... Levodopa (LD) administered in combination with carbidopa (CD) is the most effective oral treatment for Parkinson's disease (PD) motor symptoms [[1], [2], [3]].

4. neurology.org neurology.org/doi/10.1212/WNL.0000000000211199

Impact of Concomitant Therapy with a Dopamine Agonist ... Results: In the full patient population, conversion from IR CD-LD to CREXONT improved GOT by 1.74h while reducing average dosing frequency from ...

5. crexonthcp.com crexonthcp.com/the-crexont-difference/

The CREXONT Difference CREXONT (carbidopa and levodopa) extended-release capsules for oral use is indicated for the treatment of Parkinson's disease, post-encephalitic parkinsonism, ...

6. crexonthcp.com crexonthcp.com/safety/

Safety CREXONT® (carbidopa and levodopa) extended-release capsules demonstrated a well-tolerated safety profile in a head-to-head study vs optimized IR CD/LD.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/217186s000lbl.pdf

highlights of prescribing information - accessdata.fda.gov The safety population consisted of 589 patients with Parkinson's disease who received CREXONT for up to 76 weeks and had an average duration of exposure of 35 ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/carbidopa-and-levodopa-oral-route/description/drg-20095211

Carbidopa and levodopa (oral route) - Side effects & dosage Carbidopa and levodopa combination is used to treat Parkinson's disease, sometimes called shaking palsy or paralysis agitans.

9. crexonthcp.com crexonthcp.com/

CREXONT® (carbidopa and levodopa) extended-release ... CREXONT® (carbidopa and levodopa) extended-release capsules deliver more “Good On” time with less frequent dosing—as shown in a head-to-head study vs ...

10. pdexpertinstitute.com pdexpertinstitute.com/crexont-publications/

CREXONT® (carbidopa and levodopa) Extended-Release ... IMPORTANT SAFETY INFORMATION · INDICATION and Usage · Dosage and Administration · Contraindications · Warnings and Precautions · Adverse Reactions · Drug Interactions.