CTC-413 for Parkinson's Disease

Overseen By minako koga

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Chase Therapeutics Corporation

Must not be taking: Pramipexole, Dopamine antagonists, Warfarin, others

Disqualifiers: Pregnancy, Renal impairment, Hepatic impairment, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for people with Parkinson's disease to assess its safety and effectiveness. Participants will take a medication called pramipexole ER, sometimes combined with aprepitant, an anti-nausea drug. The trial seeks participants diagnosed with Parkinson's disease who have not yet received certain Parkinson's medications. Ideal candidates are those whose Parkinson’s symptoms disrupt daily life. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires you to stop taking certain medications, including pramipexole, centrally acting dopamine antagonists, pimozide, strong CYP3A4 inducers or inhibitors, warfarin, and hormonal contraceptives. If you are on any of these, you will need to stop them before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pramipexole ER is safe for treating Parkinson's disease. It performs as well as the regular version, pramipexole IR, without causing additional side effects. Long-term studies have found that pramipexole ER is well-tolerated at doses ranging from 0.375 mg to 4.5 mg per day.

Regarding aprepitant, safety data from the past decade indicates it is well-tolerated, with most people not experiencing serious side effects. Overall, both pramipexole ER and aprepitant have demonstrated good safety records based on past studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's Disease?

Unlike most treatments for Parkinson's disease that focus on managing symptoms with standard medications like levodopa or dopamine agonists, CTC-413 combines Pramipexole ER with or without aprepitant, which targets both dopamine receptors and potentially modulates neurotransmitter pathways differently. This combination could offer enhanced symptom control or reduced side effects. Researchers are excited because this dual approach may provide a more comprehensive management of Parkinson's symptoms, potentially improving quality of life for patients.

What evidence suggests that this treatment might be an effective treatment for Parkinson's Disease?

Research has shown that pramipexole ER, which participants in this trial may receive, helps treat Parkinson's disease. Studies indicate it improves patients' quality of life and outperforms a placebo. Specifically, patients who switched to pramipexole ER experienced up to a 15% improvement in their symptoms based on the Parkinson Disease Rating Scale. Research suggests that aprepitant, another treatment option in this trial, may protect brain cells, which could benefit Parkinson's patients. Although data on aprepitant's effectiveness for Parkinson's is limited, its potential to protect the brain is promising. Together, these treatments might offer a helpful option for those with Parkinson's. ^{2 5 6 7 8}

Who Is on the Research Team?

Kitty Clarence-Smith, md

Principal Investigator

KM Pharmaceutical Consulting

Are You a Good Fit for This Trial?

This trial is for men and women aged 40-80 with a diagnosis of idiopathic Parkinson's disease, who haven't been treated with CD/LD and are in the Hoehn & Yahr stages 2 to 3. Excluded are pregnant or nursing women, recent participants in other trials, those with significant heart issues or severe kidney/liver problems, allergies to study meds, or on certain drugs like Warfarin.

Inclusion Criteria

I am between 40 and 80 years old.

I have been diagnosed with Parkinson's disease.

I have never been treated with CD/LD.

Exclusion Criteria

I have not taken pramipexole or aprepitant in the last 3 months.

My kidneys are not working well (Creatinine Clearance: < 60 mL/min).

Patients considered unlikely to cooperate in the study, and/or poor compliance anticipated by the investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants switch from their dopaminergic treatment to pramipexole ER, titrated to optimal dose or 4.5 mg/day

Approximately 4-6 weeks

Weekly in-clinic visits

Treatment Part 2

Add-on aprepitant and continue titration of pramipexole ER to optimal dose not exceeding 9.0 mg/day

Approximately 4-6 weeks

Weekly in-clinic visits

Treatment Part 3

Maintain optimal pramipexole ER/aprepitant regimen for 3 months with periodic safety and efficacy checks

3 months

Monthly in-clinic evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aprepitant
• Pramipexole ER

Trial Overview The trial is testing CTC-413 which includes pramipexole ER combined with aprepitant for safety and initial effectiveness in treating parkinsonian disorders. It's a Phase 2 study where patients agree to follow all procedures required by the research team.

How Is the Trial Designed?

Group I: CTC-413 Experimental Treatment 1 Intervention

Pramipexole with/with out aprepitant orally once daily

Who Is Running the Clinical Trial?

Chase Therapeutics Corporation

Lead Sponsor

Trials

2

Recruited

50+

Published Research Related to This Trial

Pramipexole, a non-ergot dopamine agonist, is effective in treating both the motor and non-motor symptoms of Parkinson's disease, including depression, and is now available in an extended-release formulation for improved compliance and continuous effect over 24 hours.

While pramipexole is generally well tolerated, it has a higher incidence of certain dopaminergic side effects compared to traditional levodopa treatment, which should be considered when evaluating the benefit-risk ratio for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of pramipexole in the management of Parkinson's disease. Antonini, A., Barone, P., Ceravolo, R., et al.[2021]

In a phase II study involving 78 advanced Parkinson's disease patients, pramipexole significantly improved motor function and daily activities, with a 37.3% reduction in UPDRS total scores compared to 12.2% for placebo (p<0.001).

Pramipexole was well tolerated, with no unexpected safety issues, although some patients experienced fatigue, dyskinesia, and vivid dreams; it also reduced 'off' periods by 12%, leading to 1.7 more hours of 'on' time per day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study. Pinter, MM., Pogarell, O., Oertel, WH.[2019]

Pramipexole, in its extended-release formulation, has demonstrated long-term safety and efficacy in treating both early and advanced Parkinson's disease, with treatment durations of up to 113 weeks across multiple studies involving 902 subjects.

Common adverse events included somnolence and dyskinesia, but overall, patients showed sustained improvements in their Parkinson's symptoms as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease. Hauser, RA., Schapira, AH., Barone, P., et al.[2022]

Pramipexole extended-release (ER) significantly improved symptoms in Parkinson's disease compared to placebo, as shown by a notable reduction in Unified Parkinson's Disease Rating Scale (UPDRS) scores across six randomized controlled trials.

Pramipexole ER demonstrated similar safety profiles to pramipexole immediate-release (IR), with no significant differences in adverse events, indicating that both formulations are equally safe for treating Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of pramipexole extended-release in Parkinson's disease: a review based on meta-analysis of randomized controlled trials. Shen, T., Ye, R., Zhang, B.[2018]

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]

Citations

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antiemetic-activity-of-fosaprepitant-as-a-rescue-agent-in- ... In this study, aprepitant exhibited some potential in treating established (CINV), although the data did not reach expected outcome measures set ...

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NCT01432015 | Fosaprepitant Versus Aprepitant in the ... Nausea and vomiting are two of the more concerning adverse outcomes associated with chemotherapy in the treatment of gynecologic malignancies. In fact, nearly ...

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Fosaprepitant - an overview Oral doses of rolapitant appear to be rapidly absorbed and well tolerated without significant side effects. A dose-response study reported that rolapitant ...

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A real-world study to evaluate the safety and efficacy of three ... In this real-world analysis, patients receiving CINVANTI® had a reduced need for CINV rescue therapy and a numerically lower incidence of infusion reactions.