220 Participants Needed

CREXONT ER for Parkinson's Disease

Recruiting at 24 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Impax Laboratories, LLC
Must be taking: CD-LD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Who Is on the Research Team?

HV

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)
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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
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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?
1Treatment groups
Experimental Treatment
Group I: CREXONT ERExperimental Treatment1 Intervention

Find a Clinic Near You

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.
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.
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.
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

Meta-analysis of the adverse events associated with extended-release versus standard immediate-release pramipexole in Parkinson disease. [2022]
[Pramipexol: a new dopaminergic agonist for the treatment of Parkinson disease]. [2018]
Randomized, double-blind study of pramipexole with placebo and bromocriptine in advanced Parkinson's disease. [2018]
Alpha-dihydroergocryptine in the long-term therapy of Parkinson's disease. [2017]
Randomized, double-blind, multicenter evaluation of pramipexole extended release once daily in early Parkinson's disease. [2022]
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