What is the mechanism of action of this treatment?

The most common treatments for Parkinson's Disease (PD) primarily aim to increase dopamine levels or mimic its action in the brain, addressing the dopamine deficiency that characterizes the condition. Dopamine agonists like Pramipexole ER directly stimulate dopamine receptors, providing symptomatic relief and reducing motor symptoms. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, effectively replenishing dopamine levels. MAO B inhibitors prevent the breakdown of dopamine, prolonging its action. These treatments are crucial for PD patients as they help manage motor symptoms, improve quality of life, and maintain functional abilities.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease, particularly dopamine agonists such as Pramipexole ER, are associated with several side effects. These include nausea, somnolence, dizziness, headache, and orthostatic hypotension. More serious adverse reactions can include confusion, hallucinations, delusions, agitation, psychosis, and impulse control disorders. Additionally, dopamine agonists may cause nonmotor side effects like edema, constipation, and increased risk of compulsive behaviors.

What prior FDA approvals exist?

Several dopamine agonists have been approved by the FDA for the treatment of Parkinson's Disease. Pramipexole, available in both immediate-release and extended-release (ER) formulations, is one such drug. Other notable dopamine agonists include ropinirole, which also comes in immediate and extended-release forms, and rotigotine, which is administered via a transdermal patch. These medications work by stimulating dopamine receptors in the brain, thereby helping to manage motor symptoms associated with Parkinson's Disease. The development and approval of these drugs have provided significant options for patients and clinicians in managing the disease.

What other types of research exist?

Promising novel alternatives to Pramipexole ER for Parkinson's Disease patients include: 1) Opicapone, a COMT inhibitor, which has shown efficacy in reducing 'off' time when used as an adjunct to levodopa. 2) Safinamide, a MAO-B inhibitor, which has demonstrated benefits in managing motor fluctuations. 3) Sodium oxybate, which has shown potential in improving excessive daytime sleepiness in PD patients, though further studies are needed. These alternatives offer different mechanisms of action and can be considered based on individual patient needs and responses.

← Back to Search

Dopamine Agonist

CTC-413 for Parkinson's Disease

Phase 2

Waitlist Available

Research Sponsored by Chase Therapeutics Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females aged 40 - 80 years inclusive

Have not previously been treated with CD/LD

Must not have

Individuals who have taken a study medication (pramipexole and/or aprepitant) within 3 months of study admission

Moderate and severe renal impairment (Creatinine Clearance: < 60 mL/min calculated by Cockcroft and Gault equation)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up mulitple times from baseline through month 3

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include nausea due to aprepitant (commonly used for preventing chemotherapy-induced nausea), dizziness or sleepiness from pramipexole (often used in PD treatment), as well as possible low blood pressure or heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 80 years old.

Select...

I have never been treated with CD/LD.

Select...

My Parkinson's disease is moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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

Select...

I have low blood pressure or abnormal heart rhythm.

Select...

I have severe liver problems.

Select...

I am pregnant or might become pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ multiple times from baseline through month 3

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~multiple times from baseline through month 3

This trial's timeline: 3 weeks for screening, Varies for treatment, and multiple times from baseline through month 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events

Number of participants with change in Electrocardiography (ECG)

Number of participants with change in in clinical laboratory evaluations

+2 more

Secondary study objectives

Pharmacokinetics of pramipexole and aprepitant

Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

modified Columbia-Suicide Severity Rating Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CTC-413Experimental Treatment1 Intervention

Pramipexole with/with out aprepitant orally once daily

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Parkinson's Disease (PD) primarily aim to increase dopamine levels or mimic its action in the brain, addressing the dopamine deficiency that characterizes the condition. Dopamine agonists like Pramipexole ER directly stimulate dopamine receptors, providing symptomatic relief and reducing motor symptoms. Levodopa, often combined with carbidopa, is converted to dopamine in the brain, effectively replenishing dopamine levels. MAO B inhibitors prevent the breakdown of dopamine, prolonging its action. These treatments are crucial for PD patients as they help manage motor symptoms, improve quality of life, and maintain functional abilities.

Pharmacologic approaches to the treatment of Huntington's disease.