A Study to Evaluate in Patients With Parkinsonian Type Disorders

NCT03683225 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTC-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Idiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (5)

• 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;

  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

  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)

  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,

  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).

  multiple times for the duration of the study (baseline through Month 3)

Secondary Outcomes (3)

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

  multiple times from baseline through Month 3

• modified Columbia-Suicide Severity Rating Scale

  multiple times from baseline through Month 3

• Pharmacokinetics of pramipexole and aprepitant

  multiple times from baseline through Month 3

Study Arms (1)

CTC-413

EXPERIMENTAL

Pramipexole with/with out aprepitant orally once daily

Combination Product: CTC-413

Interventions

CTC-413 COMBINATION_PRODUCT

pramipexole ER, given with aprepitant

CTC-413

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Chase Therapeutics Corporation: lead

Study Sites (1)

Quest Research

Farmington Hills, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Kitty Clarence-Smith, md

  KM Pharmaceutical Consulting

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 25, 2018
• Study Start: April 1, 2019
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

US (1)