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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up mulitple times from baseline through month 3
Awards & highlights
Study Summary
This trialstudies if a drug combo can help treat Parkinson's-like disorders safely and effectively.
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.Check my eligibility
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.See study design
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 belowSelect...
I am between 40 and 80 years old.
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I have never been treated with CD/LD.
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My Parkinson's disease is moderate.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
Pharmacokinetics of pramipexole and aprepitant
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
modified Columbia-Suicide Severity Rating Scale
Trial Design
1Treatment groups
Experimental Treatment
Group I: CTC-413Experimental Treatment1 Intervention
Pramipexole with/with out aprepitant orally once daily
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Who is running the clinical trial?
Chase Therapeutics CorporationLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Kitty Clarence-Smith, mdStudy DirectorKM Pharmaceutical Consulting
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have low blood pressure or abnormal heart rhythm.I am between 40 and 80 years old.I have severe liver problems.I have been diagnosed with Parkinson's disease.I have never been treated with CD/LD.I am pregnant or might become pregnant.I do not have any health conditions that could make this trial unsafe for me.My Parkinson's disease is moderate.
Research Study Groups:
This trial has the following groups:- Group 1: CTC-413
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the subject pool for this experiment limited to those under 45?
"The target demographic of this clinical trial are individuals over the age of 40 and not exceeding 80 years old."
Answered by AI
Is there the possibility of participating in this medical research endeavor?
"To be accepted into this medical experiment, patients must have a diagnosis of Parkinson's disease and fall between the ages of 40-80. The clinical trial aims to recruit approximately 24 participants."
Answered by AI
What safety measures have been identified for CTC-413 administration?
"Since this is only a Phase 2 trial, with clinical data substantiating safety but no evidence of efficacy yet, CTC-413 was assigned an interim score of 2."
Answered by AI
Are there still opportunities for eligible individuals to participate in this study?
"Clinicaltrials.gov reveals that this medical trial, initially published on April 1st 2019 and last updated on the 9th of April 2019, is not recruiting any participants at present. However, there are 481 other research projects currently seeking out volunteers."
Answered by AI
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