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

24 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug CTC-413 for Parkinson's Disease?

Research shows that pramipexole, a component of CTC-413, is effective and safe for treating Parkinson's disease, both in early and advanced stages. It helps manage symptoms and is well-tolerated by patients, according to multiple studies. ^{1 2 3 4 5}

Is pramipexole safe for humans?

Pramipexole, used for Parkinson's disease, is generally well tolerated, but it may have more dopaminergic side effects (related to dopamine, a brain chemical) compared to some other treatments. It has been studied in both early and advanced stages of the disease, showing a good safety profile in long-term use. ^{1 3 5 6 7}

How is the drug Pramipexole ER unique in treating Parkinson's disease?

Pramipexole ER is unique because it is an extended-release formulation that provides a more continuous therapeutic effect over 24 hours, improving ease of use and compliance. It acts as a non-ergot dopamine agonist with a high affinity for the D3 receptor, offering potential neuroprotective effects and benefits beyond motor symptom relief, such as improving depressive symptoms in Parkinson's disease. ^{2 3 7 8 9}

What is the purpose of this trial?

This trial tests a combination of Pramipexole ER and Aprepitant in patients with idiopathic Parkinson's disease. Pramipexole ER helps reduce Parkinson's symptoms by mimicking dopamine, while Aprepitant prevents nausea to improve tolerance of the treatment. Pramipexole is used to treat Parkinson's disease and is effective in both early and advanced stages.

Research Team

Kitty Clarence-Smith, md

Principal Investigator

KM Pharmaceutical Consulting

Eligibility Criteria

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).

I am currently taking medications like Pramipexole, Warfarin, or hormonal contraceptives.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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, 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]

References

1. England 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. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease. [2019]

3. England 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. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Pramipexole for levodopa-induced complications in Parkinson's disease. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Long-term safety and sustained efficacy of extended-release pramipexole in early and advanced Parkinson's disease. [2022]

6. 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]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Role of pramipexole in the management of Parkinson's disease. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Pramipexole. A review of its use in the management of early and advanced Parkinson's disease. [2018]

9. Japan pubmed.ncbi.nlm.nih.gov

[Pharmacological profiles and clinical effects of antiparkinsonian agent, pramipexole]. [2019]