Idiopathic Parkinson DiseasePhase 2NCT03683225
A Study to Evaluate in Patients With Parkinsonian Type Disorders
A Phase 2 study testing CTC-413 in people with Idiopathic Parkinson Disease, run by Chase Therapeutics Corporation at 1 site in United States.
Trial summary
A Phase 2 study to evaluate the safety, tolerability and initial efficacy of pramipexole ER, given with aprepitant in patients with parkinsonian type disorders Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Idiopathic Parkinson Disease
- What is being tested?
- CTC-413
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate eligibility of the study.
- Males and females aged 40 - 80 years inclusive.
- Meet criteria for the diagnosis of possible/ probable idiopathic Parkinson's disease (PD; Postuma RB, et al. 2015)
- Have not previously been treated with CD/LD.
- PD severity in the Hoehn \& Yahr 2 to 3 range.
Who cannot join
- Women who are pregnant or may become pregnant.
- Nursing mothers.
- 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)
- Severe hepatic impairment (Child-Pugh C)
- Hypersensitivity to any component of either study medication
Show all 17Show fewer
- Being treated with the following medications:
- Pramipexole
- Centrally acting dopamine antagonists during preceding month
- Pimozide
- Strong CYP3A4 inducer or inhibitor
- Warfarin (a CYP2C9 substrate)
- Hormonal contraceptives
- Patients considered unlikely to co-operate in the study, and/or poor compliance anticipated by the investigator.
- Patients who have any clinically significant hypotension or ECG abnormality.
- Any other clinically relevant acute or chronic diseases which could interfere with patients' safety during the trial, or expose them to undue risk, or which could interfere with study objectives.
- Patients who have participated in another clinical trial with an investigational drug within previous 30 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study to Evaluate the Safety, Tolerability and Initial Efficacy of Pramipexole ER, Given With Aprepitant in Patients With Idiopathic Parkinson's Disease
A Phase 2 study to evaluate the safety, tolerability and initial efficacy of pramipexole ER, given with aprepitant in patients with parkinsonian type disorders
Read the detailed description
Methodology:
This is an initial Phase 2, rising-dose, single-blind, out-patient, sequential-treatment study in up to 24 patients with idiopathic Parkinson's disease of about 5 months duration. All participants will have idiopathic Parkinson's disease (PD).
Subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments.
The study will be conducted in three parts:
Part 1: All eligible patients switch from their dopaminergic treatment to the equivalent dose of pramipexole ER in the judgement of the investigator. Then, pramipexole ER is titrated alone up to the patients' optimal dose or to the protocol maximum allowed dose for Part 1 of 4.5 mg/day.
Part 2: Add-on aprepitant and continue the titration of pramipexole ER from the optimal dose (or 4.5 mg/day) determined in Part 1 to the optimal dose not to exceed the protocol limit of 9.0mg/day, given in combination with aprepitant.
Part 3: Maintain the dose of pramipexole ER found in Part 2 given in combination with aprepitant for 3 months with periodic safety and efficacy checks.
During Parts 1 and 2, subjects will be evaluated at in-clinic visits for safety and tolerability at intervals not to exceed once weekly ± 2 days and additionally by telephone or in-clinic visits, as considered clinically appropriate, at each dose change.
During Part 3, this optimal pramipexole ER/aprepitant regimen will be stably maintained for 3 months in association with monthly in-clinic laboratory and clinical evaluations. Safety and tolerability will continue to be evaluated by telephone or in-clinic visits, as deemed clinically appropriate.
Pramipexole ER tablets will be administered with or without aprepitant, orally once daily in the morning. Subjects will take 1-3 pramipexole ER tablets daily.
Aprepitant will be administered orally in a fixed daily dose by means of a single capsule containing 80 mg.
At study completion (or at other times in accordance with Stopping Rules given below), study medications will be discontinued, and participants will be returned to their pre-admission therapeutic regimen as considered medically appropriate. Investigators will always have the option of making necessary and appropriate changes to protocol dose optimization schedules in consultation with the Sponsor.
An independent DSMB will be appointed to have responsibility for safeguarding the interests of the trial subjects and assessing the safety and tolerability of the study treatments during the trial. The DSMB will meet when 10 patients complete the study and when all patients complete the study.
- Conditions
- Idiopathic Parkinson Disease
- Being tested
- CTC-413
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC-413Combination product
pramipexole ER, given with aprepitant
| Study group | Role | What they receive |
|---|---|---|
| CTC-413 | Experimental | Pramipexole with/with out aprepitant orally once daily Receives: Combination Product: CTC-413 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
Measured: multiple times for the duration of the study (baseline through Month 3)
Number of participants with change in weight
Number of participants with a change in weight (either by pounds or kilograms) from baseline
Measured: mulitple times from baseline through Month 3
Number of participants with change in in physical examine
physical examination changes General appearance,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Measured: multiple times for the duration of the study (baseline through Month 3)
Number of participants with change in in clinical laboratory evaluations
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
Measured: multiple times for the duration of the study (baseline through Month 3)
Number of participants with change in Electrocardiography (ECG)
ECG (standard digital 12-lead in singlicate).
Measured: multiple times for the duration of the study (baseline through Month 3)
Secondary outcomes (3)
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Change from baseline in the MDS-UPDRS Part 4 for motor fluctuations and dyskinesia severity will be assessed hourly x3 on assessment days.motor complications (six items). Subscale has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. Total score 0-24.
Measured: multiple times from baseline through Month 3
modified Columbia-Suicide Severity Rating Scale
3 question scale to to gage is the subject is having suicidal tendencies. If the response is "YES" to Question 1 or 2, or if the response to Question 3 reveals a concern about a significant level of suicidality, the subject would undergo a more detailed assessment by a qualified clinician who has experience in the evaluation of suicidal ideation and behavior, either at the site or by referral to an outside clinician. In either case, appropriate documentation of the clinical issues and management plan will be required in a narrative that would be placed in the subject's study record. Questions are 'yes' or 'no'
Measured: multiple times from baseline through Month 3
Pharmacokinetics of pramipexole and aprepitant
Plasma concentrations of pramipexole and aprepitant will be measured
Measured: multiple times from baseline through Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Apr 2019
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pramipexole ER tablets will be administered with or without aprepitant, orally once daily in the morning. During Part 1 and Part 2, pramipexole ER dosage will be adjusted in twice-weekly increments of 0.75 mg/day as guided by efficacy and tolerability (see table above). Aprepitant: From study Part 2 onwards, participants will also receive one 80 mg capsule of aprepitant co-administered once daily with pramipexole ER.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chase Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kitty Clarence-Smith, md, Study director, KM Pharmaceutical Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683225
- Sponsor's protocol ID
- CTC-002
- Status last verified
- Jul 2024
- First submitted
- 18 Sep 2018
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety, Tolerability and Initial Efficacy of Pramipexole ER, Given With Aprepitant in Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03683225
- Acronym / sponsor ID
- CTC-002
- Conditions
- Idiopathic Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chase Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study to evaluate the safety, tolerability and initial efficacy of pramipexole ER, given with aprepitant in patients with parkinsonian type disorders
Detailed description
Methodology:
This is an initial Phase 2, rising-dose, single-blind, out-patient, sequential-treatment study in up to 24 patients with idiopathic Parkinson's disease of about 5 months duration. All participants will have idiopathic Parkinson's disease (PD).
Subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments.
The study will be conducted in three parts:
Part 1: All eligible patients switch from their dopaminergic treatment to the equivalent dose of pramipexole ER in the judgement of the investigator. Then, pramipexole ER is titrated alone up to the patients' optimal dose or to the protocol maximum allowed dose for Part 1 of 4.5 mg/day.
Part 2: Add-on aprepitant and continue the titration of pramipexole ER from the optimal dose (or 4.5 mg/day) determined in Part 1 to the optimal dose not to exceed the protocol limit of 9.0mg/day, given in combination with aprepitant.
Part 3: Maintain the dose of pramipexole ER found in Part 2 given in combination with aprepitant for 3 months with periodic safety and efficacy checks.
During Parts 1 and 2, subjects will be evaluated at in-clinic visits for safety and tolerability at intervals not to exceed once weekly ± 2 days and additionally by telephone or in-clinic visits, as considered clinically appropriate, at each dose change.
During Part 3, this optimal pramipexole ER/aprepitant regimen will be stably maintained for 3 months in association with monthly in-clinic laboratory and clinical evaluations. Safety and tolerability will continue to be evaluated by telephone or in-clinic visits, as deemed clinically appropriate.
Pramipexole ER tablets will be administered with or without aprepitant, orally once daily in the morning. Subjects will take 1-3 pramipexole ER tablets daily.
Aprepitant will be administered orally in a fixed daily dose by means of a single capsule containing 80 mg.
At study completion (or at other times in accordance with Stopping Rules given below), study medications will be discontinued, and participants will be returned to their pre-admission therapeutic regimen as considered medically appropriate. Investigators will always have the option of making necessary and appropriate changes to protocol dose optimization schedules in consultation with the Sponsor.
An independent DSMB will be appointed to have responsibility for safeguarding the interests of the trial subjects and assessing the safety and tolerability of the study treatments during the trial. The DSMB will meet when 10 patients complete the study and when all patients complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pramipexole ER tablets will be administered with or without aprepitant, orally once daily in the morning. During Part 1 and Part 2, pramipexole ER dosage will be adjusted in twice-weekly increments of 0.75 mg/day as guided by efficacy and tolerability (see table above). Aprepitant: From study Part 2 onwards, participants will also receive one 80 mg capsule of aprepitant co-administered once daily with pramipexole ER.
| Arm | Type | Receives |
|---|---|---|
| CTC-413 | Experimental | Combination Product: CTC-413Pramipexole with/with out aprepitant orally once daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient must have signed an Institutional Review Board (IRB) approved informed consent document indicating that they understand the purpose of and procedures required by the study and are willing to participate in the study and comply with all study procedures and restrictions. Informed consent must be obtained from the patient and/or a designated representative prior to initiating screening procedures to evaluate eligibility of the study.
- Males and females aged 40 - 80 years inclusive.
- Meet criteria for the diagnosis of possible/ probable idiopathic Parkinson's disease (PD; Postuma RB, et al. 2015)
- Have not previously been treated with CD/LD.
- PD severity in the Hoehn \& Yahr 2 to 3 range.
Key exclusion criteria (17 listed)
- Women who are pregnant or may become pregnant.
- Nursing mothers.
- 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)
- Severe hepatic impairment (Child-Pugh C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC-413pramipexole ER, given with aprepitant | Combination product | CTC-413 |
Primary outcome
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events
Time frame: multiple times for the duration of the study (baseline through Month 3)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0" . Incidence and nature of adverse events; vital signs;
Number of participants with change in weight
Time frame: mulitple times from baseline through Month 3
Number of participants with a change in weight (either by pounds or kilograms) from baseline
Number of participants with change in in physical examine
Time frame: multiple times for the duration of the study (baseline through Month 3)
physical examination changes General appearance,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
Number of participants with change in in clinical laboratory evaluations
Time frame: multiple times for the duration of the study (baseline through Month 3)
changes in clinical laboratory evaluations (Creatinine, Potassium(K+),Sodium (Na+) , Chloride (Cl-), Magnesium (Mg++), Calcium, Inorganic phosphate, Glucose, Urea,Bilirubin (Total) ,Bilirubin (direct), AST, ALT, GGT, Alkaline phosphatase, Total Protein Albumin,
Number of participants with change in Electrocardiography (ECG)
Time frame: multiple times for the duration of the study (baseline through Month 3)
ECG (standard digital 12-lead in singlicate).
3 secondary outcomes
Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: multiple times from baseline through Month 3
modified Columbia-Suicide Severity Rating Scale
Time frame: multiple times from baseline through Month 3
Pharmacokinetics of pramipexole and aprepitant
Time frame: multiple times from baseline through Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kitty Clarence-Smith, md study director
KM Pharmaceutical Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CTC-413 in people with Idiopathic Parkinson Disease, run by Chase Therapeutics Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent Adverse Events (time frame: multiple times for the duration of the study (baseline through Month 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024; AzTrials last refreshed its copy on 26 Oct 2026.