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A Randomized, Double-Blind, Placebo-Controlled Trial of IkT-148009 in Untreated Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05424276
Recruitment Status : Recruiting
First Posted : June 21, 2022
Last Update Posted : May 18, 2023
Sponsor:
Information provided by (Responsible Party):
Inhibikase Therapeutics, Inc.

Study Description
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Brief Summary:
This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 75 years old). It also looks at the pharmacokinetics of IkT-148009 in the body and evaluates the effect of IkT-148009 on motor and non-motor features of the disease. This 12 week study is designed to be 2:1 randomized across 2 doses of IkT-148009 or placebo. Each participant will self-administer one of 2 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: IkT-148009 Drug: Placebo Phase 2

Detailed Description:

This is a 12-Week, randomized, double-blind, multi-center, placebo-controlled dose-ranging clinical trial of three IkT 148009 doses in patients with untreated PD designed to assess safety, tolerability, and pharmacokinetics of IkT-148009, an oral, once daily c-Abl tyrosine kinase inhibitor. Secondary and exploratory assessments will evaluate the effect of IkT-148009 on motor and non-motor features of the disease. 90 participants are anticipated to be enrolled at up to 40 sites across the US.

Participants will undergo screening to evaluate their eligibility to participate in the study to include evaluation of Parkinson's diagnosis, vital signs, blood chemistry, hematology and urinalysis and complete listing of concomitant medications. An Enrollment Authorization Committee (EAC) will be responsible for reviewing screening data and confirming the eligibility and suitability of participants. Those selected will be enrolled and randomized to one of two active IkT-148009 arms (50/100 mg) or a placebo arm (1:1:1). All clinical staff, study investigators, and participants will be blinded to study assignments throughout the trial.

A Data Safety Monitoring Committee (DSMB) will evaluate all available safety, tolerability, and PK and Parkinson's disease-related data for each cohort on a monthly to quarterly basis. Adverse event reporting will be evaluated in real-time.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 50mg IkT-148009
This arm will consist of thirty (30) patients on 50mg of active treatment.
 Drug: IkT-148009
Oral administration gelatin capsule
Experimental: 100mg IkT-148009
This arm will consist of thirty (30) patients on 100mg of active treatment.
 Drug: IkT-148009
Oral administration gelatin capsule
Placebo Comparator: Placebo
This arm will consist of thirty (30) patients on placebo.
 Drug: Placebo
Oral administration gelatin capsule


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and temporal profile of treatment-emergent adverse events (TEAEs) evaluated by type/nature, severity/intensity, seriousness, and relationship to study intervention [ Time Frame: Day 1 through week 16 ]
  2. Proportion of those randomized in each dosing cohort who discontinued the assigned regimen [ Time Frame: Day 1 through week 12 ]

Secondary Outcome Measures :
  1. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts II + III [ Time Frame: Change from Baseline to Week 12 ]
    Higher scores mean worse outcome from 0 to 52

  2. Patient Global Impression-Severity (PGI-S) [ Time Frame: Change from Baseline to Week 12 ]
    Scale varies from None to Very Severe

  3. Clinician Global Impression of Severity (CGI-S) [ Time Frame: Change from Baseline to Week 12 ]
    Higher scores mean worse outcome between 1 and 7.

  4. Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I [ Time Frame: Change from Baseline to Week 12 ]
    Higher scores mean worse outcome from 0 to 52.

  5. Non-Motor Symptom Scale (NMSS) [ Time Frame: Change from Baseline to Week 12 ]
    Higher scores mean worse outcome from 0 to 360.

  6. Complete Spontaneous Bowel Movement (CSBM) [ Time Frame: Change from Baseline to Week 12 ]
    A value < 3 implies constipation

  7. Epworth Sleepiness Scale (ESS) [ Time Frame: Change from Baseline to Week 12 ]
    Higher score means worse outcome from 0 to 24.

  8. Schwab and England Activities of Daily Living (SE-ADL) Scale [ Time Frame: Change from Baseline to Week 12 ]
    Higher score means worse outcome from 0% to 100%

  9. Parkinson's Disease Questionnaire (PDQ-39) [ Time Frame: Change from Baseline to Week 12 ]
    Higher scores mean worse outcome from 0 to 100.

  10. Patient Assessment of Upper Gastrointestinal Disorders Severity Index (PAGI-SYM) [ Time Frame: Change from Baseline to Week 12 ]
    Higher score means worse outcome from 0 to 100.

  11. Patient Assessment of Constipation Quality of Life (PAC-QOL) [ Time Frame: Change from Baseline to Week 12 ]
    Higher score means worse outcome from 0 to 150.

  12. Patient Assessment of Gastrointestinal Disorders Severity Quality of Life (PAGI- QOL) [ Time Frame: Change from Baseline to Week 12 ]
    Higher score means worse outcome from 0 to 150.


Other Outcome Measures:
  1. Phosphorylated alpha-synuclein in cerebrospinal fluid (CSF) [ Time Frame: Change from Baseline to Week 12 ]
    Detection of the presence or absence of phosphorylated alpha-synuclein in CSF

  2. Phosphorylated alpha-synuclein in skin [ Time Frame: Change from Baseline to Week 12 ]
    Detection of the presence or absence of phosphorylated alpha-synuclein in peripheral nerve biopsy in skin


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Participants who are diagnosed with PD consistent with UK Brain Bank criteria and MDS Research Criteria; must include bradykinesia with sequence effect and motor asymmetry.
  2. Receiving no anti-parkinsonian therapy
  3. Modified Hoehn/Yahr Stage < 3.0
  4. Montreal Cognitive Assessment ≥ 26
  5. Patient expected to be able to participate in trial without need for additional anti-parkinsonian therapy

Sex and Contraceptive/Barrier Requirements:

  1. Male participants must agree to practice an acceptable method of highly effective birth control from the screening visit, while on study and for 30 days after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence, vasectomy, or a condom with spermicide (men) in combination with their partner's highly effective method.
  2. Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to either remain abstinent or use adequate and reliable contraception throughout the study and at least 30 days after the last dose of study drug has been taken.

Informed Consent:

1. Capable of giving signed ICF as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Other Inclusions:

1. Approved as an appropriate and suitable candidate by the EAC.

Exclusion Criteria

  1. Diagnosis/suspicion of secondary or atypical parkinsonism
  2. Previous procedure or surgery for PD, or anticipation of these during the study
  3. High likelihood of needing anti-parkinsonian treatment over the study period, in the opinion of the investigator
  4. Clinically significant orthostatic hypotension
  5. Clinically significant hallucinations requiring antipsychotic use in the 12 months prior to Screening
  6. Clinically significant medical, surgical, psychiatric, or laboratory abnormalities in the judgement of the treating investigator or the EAC

Prior/Concomitant Therapy:

  1. Past treatment with levodopa, dopaminergic agonists, monoamine oxidase-B inhibitors, or A2A antagonists for more than 28 days, or treatment with any of these medications within 28 days prior to screening
  2. Past treatment with irreversible monoamine oxidase-B inhibitors (e.g., selegiline) for more than 28 days; must be discontinued for at least 90 days before screening
  3. Currently receiving moderate or strong Cytochrome P450 (CYP) 3A4/5 inducers or CYP3A4/5 inhibitors (except for topical administration)
  4. Currently receiving any antipsychotic, metoclopramide, reserpine, or amphetamine.

Prior/Concurrent Clinical Study Experience:

  1. Current participation in another investigational clinical trial and/or receipt of any investigational medication within 90 days prior to screening
  2. Previous randomization into this or another IkT-148009 study

Diagnostic Assessments:

  1. Active suicidal ideation within one year prior to screening visit, as determined by the Columbia Suicide Rating Scale (answer of "yes" on question 4 or 5)
  2. Current diagnosis or history of substance abuse (excluding nicotine or caffeine) by Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria
  3. Medical or recreational use of marijuana in the 3 months prior to the screening visit
  4. Any social or behavioral reason that would preclude completion of the study, in the judgement of the investigator
  5. Any skin condition that would interfere with obtaining adequate samples
  6. Evidence of advanced, age-related macular degeneration (neovascular or geographic atrophy) or intermediate macular degeneration as defined by Beckman classification (Large drusen > 125 um and/or any AMD pigmentary abnormalities). Evidence of retina/choroid neovascularization from any cause. Evidence of central serous retinopathy.
  7. Abnormal amylase and/or lipase at screening (may be repeated during screening period)
  8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 2.5 times the upper limit of normal (ULN)
  9. Significant renal impairment as determined by creatinine clearance (CrCL) less than or equal to 60 ml/min
  10. Currently lactating, pregnant or planning on becoming pregnant during the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05424276


Contacts
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Contact: Milton Werner, PhD 6783923419 mhwerner@inhibikase.com
Contact: Milton Werner, PhD (678) 392-3419 info@inhibikase.com

Locations
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United States, Arizona
Neurology Not yet recruiting
Scottsdale, Arizona, United States, 85258
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, California
Neurology Recruiting
Reseda, California, United States, 91335
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Connecticut
Neurologist Not yet recruiting
Stamford, Connecticut, United States, 06905
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Florida
Neurologist Not yet recruiting
Boca Raton, Florida, United States, 33486
Contact: Milton Werner, PhD       info@inhibikase.com   
Neurology Not yet recruiting
Maitland, Florida, United States, 32751
Contact: Milton Werner, PhD       info@inhibikase.com   
Neurologist Not yet recruiting
Naples, Florida, United States, 34105
Contact: Milton Werner, PhD       info@inhibikase.com   
Neurology Recruiting
Tampa, Florida, United States, 33609
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Georgia
Neurologist Not yet recruiting
Savannah, Georgia, United States, 31406
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Kansas
Neurology Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Massachusetts
Neurology Not yet recruiting
Foxboro, Massachusetts, United States, 02035
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Michigan
Neurology Recruiting
Farmington Hills, Michigan, United States, 48334
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, New Jersey
Neurology Recruiting
West Long Branch, New Jersey, United States, 07764
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, New York
Neurology Not yet recruiting
Commack, New York, United States, 11725
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, North Carolina
Neurology Recruiting
Raleigh, North Carolina, United States, 27607
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Ohio
Neurology Not yet recruiting
Columbus, Ohio, United States, 43221
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Oklahoma
Neurology Not yet recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Tennessee
Neurology Not yet recruiting
Memphis, Tennessee, United States, 38137
Contact: Milton Werner, PhD       info@inhibikase.com   
Neurology Recruiting
Memphis, Tennessee, United States, 38137
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Texas
Neurology Recruiting
Frisco, Texas, United States, 75035
Contact: Milton Werner, PhD       info@inhibikase.com   
Neurology Not yet recruiting
Round Rock, Texas, United States, 78681
Contact: Milton Werner, PhD       info@inhibikase.com   
United States, Wisconsin
Neurology Not yet recruiting
Madison, Wisconsin, United States, 53705
Contact: Milton Werner, PhD       info@inhibikase.com   
Neurology Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Milton Werner, PhD       info@inhibikase.com   
Sponsors and Collaborators
Inhibikase Therapeutics, Inc.
Investigators
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Principal Investigator: Milton Werner, PhD Inhibikase Therapeutics, Inc.
More Information
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Responsible Party: Inhibikase Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05424276    
Other Study ID Numbers: IkT-148009-201
First Posted: June 21, 2022    Key Record Dates
Last Update Posted: May 18, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Clinical Study Report (CSR)
Time Frame: End of study

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inhibikase Therapeutics, Inc.:
Untreated Parkinsons disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases