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Completed · registry status

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

A plain-language introduction is being prepared for this study. Open it to read the original description, who can join and how to contact the team.

Testing a treatment or activity · Study reference: NCT05424276

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This registry record was last updated over six months ago, or its update date is missing. Recruitment may have changed. Confirm with the team before making plans.

Open the official registry record ↗

Follow this study

Results reported

Start (reported actual date)
2023-05-15
Main measurements finished (reported actual date)
2024-10-25
Study finished (reported actual date)
2025-09-13

Planned dates can move. A study finishing does not tell us when a paper will be published.

Read the results reported in the registry ↗

Changes we have recorded
  • 2026-10-11 — completed

These are dates we observed a change, not necessarily the dates it happened.

Papers connected to this study

The 201 Trial: a placebo-controlled randomized phase 2 study of safety and tolerance of the c-Abl kinase inhibitor risvodetinib in untreated Parkinson's disease.
Listed by the registry as research derived from the study · 2026

Participation rules recorded for this study

Ages 30 years to 80 years · Does not accept healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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 ≥ 24 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, supplements containing levodopa (i.e. Mucana pruriens), or A2A antagonists for more than 28 days, or treatment with any of these medications or supplements 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 the following criteria: * Creatinine clearance (CrCL) less than or equal to 60 mL/min for subjects \< 65 years of age * Creatine clearance (CrCL) greater than or equal to 55 mL/min and the absence of proteinuria or hematuria for subjects ≥ 65 years of age 10. Currently lactating, pregnant or planning on becoming pregnant during the study
Full study name & original research details

Official study title

A Phase 2 Study of IkT-148009 in Untreated Parkinson's Disease

Short title used by the registry

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

Original description

This study investigates the safety and tolerability of drug IkT-148009 in untreated Parkinson's disease volunteers (30 to 80 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 3:1 randomized across 3 doses of IkT-148009 or placebo. Each participant will self-administer one of 3 doses or placebo of IkT-148009 once daily (QD) with food for 12 weeks. For more information, visit our website: www.the201trial.com

Further description from the registry

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. 120 participants are anticipated to be enrolled at up to 34 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 three active IkT-148009 arms (50/100/200 mg) or a placebo arm (1:1:1:1). 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.

Conditions reported: Parkinson Disease

Registry records for this study

Records are joined using registration identifiers. Titles alone do not establish that two studies are the same.

Study type
Interventional
Interventions
IkT-148009 (risvodetinib); Placebo
Phases
PHASE2
Sponsor
ABLi Therapeutics, Inc.
Start date reported by registry
2023-05-15 (actual)

Registry updated: 2025-11-19 · Status last verified by the registry submitter: 2025-10

Registry records retrieved 2026-10-12 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

No central contact is listed. Check the location contacts or the official registry record.

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Neurology

Scottsdale, Arizona, United States

Status not reported

Neurology

Little Rock, Arkansas, United States

Status not reported

Neurology

Reseda, California, United States

Status not reported

Neurology

Stamford, Connecticut, United States

Status not reported

Neurologist

Boca Raton, Florida, United States

Status not reported

Neurology

Miami, Florida, United States

Status not reported

Neurology

Naples, Florida, United States

Status not reported

Neurology

Tampa, Florida, United States

Status not reported

Neurology

Foxborough, Massachusetts, United States

Status not reported

Neurology

South Dartmouth, Massachusetts, United States

Status not reported

Neurology

Farmington Hills, Michigan, United States

Status not reported

Neurology

Golden Valley, Minnesota, United States

Status not reported

Neurology

West Long Branch, New Jersey, United States

Status not reported

Neurology

Durham, North Carolina, United States

Status not reported

Neurology

Raleigh, North Carolina, United States

Status not reported

Neurology

Columbus, Ohio, United States

Status not reported

Neurology

Tulsa, Oklahoma, United States

Status not reported

Neurology

Portland, Oregon, United States

Status not reported

Neurology

Port Royal, South Carolina, United States

Status not reported

Neurology

Memphis, Tennessee, United States

Status not reported

Neurology

Nashville, Tennessee, United States

Status not reported

Neurology

Frisco, Texas, United States

Status not reported

Neurology

Houston, Texas, United States

Status not reported

Neurology

Round Rock, Texas, United States

Status not reported

Neurology

Kirkland, Washington, United States

Status not reported

Neurology

Madison, Wisconsin, United States

Status not reported

Neurology

Milwaukee, Wisconsin, United States

Status not reported

Facility not reported

United States

Status not reported

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.