CREXONT ER for Parkinson's Disease

Recruiting at 13 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?

The primary purpose of this study is to evaluate efficacy and safety of CREXONT under real world conditions in participants with Parkinson disease (PD).

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 safety information is available for CREXONT ER in humans?

Pramipexole, which may be similar to CREXONT ER, has been studied for Parkinson's disease and is generally well-tolerated. Common side effects include sleepiness, nausea, constipation, and tiredness. ^{1 2 3 4 5}

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 (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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Spain pubmed.ncbi.nlm.nih.gov

[Pramipexol: a new dopaminergic agonist for the treatment of Parkinson disease]. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Randomized, double-blind study of pramipexole with placebo and bromocriptine in advanced Parkinson's disease. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Alpha-dihydroergocryptine in the long-term therapy of Parkinson's disease. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease. [2022]