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New pill could slow Parkinson's progression in early stages

NCT ID NCT05424276

Disease control Sponsor: ABLi Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an experimental drug called IkT-148009 (risvodetinib) in 137 people with early, untreated Parkinson's disease. Participants took one of three doses or a placebo daily for 12 weeks. The goal was to check safety and see if the drug improves movement and daily living skills. Results will help decide if larger, longer studies are worthwhile.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IkT-148009 (risvodetinib)
What this could lead to
If successful, this could point toward a new oral treatment option for early Parkinson's disease that may help control motor and non-motor symptoms without immediate need for other therapies.
What could go wrong
This is a small, 12-week Phase 2 trial with only 137 participants, so results may not apply to all Parkinson's patients. The drug may cause side effects or fail to show meaningful benefit over placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

137 people

The number who actually took part.

Started

May 2023

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • Neurologist

    Boca Raton, Florida, 33486, United States

  • Neurology

    Scottsdale, Arizona, 85258, United States

  • Neurology

    Little Rock, Arkansas, 72205, United States

  • Neurology

    Reseda, California, 91335, United States

  • Neurology

    Stamford, Connecticut, 06905, United States

  • Neurology

    Miami, Florida, 33136, United States

  • Neurology

    Naples, Florida, 34105, United States

  • Neurology

    Tampa, Florida, 33609, United States

  • Neurology

    Tampa, Florida, 33613, United States

  • Neurology

    Foxborough, Massachusetts, 02035, United States

  • Neurology

    South Dartmouth, Massachusetts, 02747, United States

  • Neurology

    Farmington Hills, Michigan, 48334, United States

  • Neurology

    Golden Valley, Minnesota, 55427, United States

  • Neurology

    West Long Branch, New Jersey, 07764, United States

  • Neurology

    Durham, North Carolina, 27705, United States

  • Neurology

    Raleigh, North Carolina, 27607, United States

  • Neurology

    Columbus, Ohio, 43221, United States

  • Neurology

    Tulsa, Oklahoma, 74136, United States

  • Neurology

    Portland, Oregon, 97239, United States

  • Neurology

    Port Royal, South Carolina, 29935, United States

  • Neurology

    Memphis, Tennessee, 38137, United States

  • Neurology

    Nashville, Tennessee, 37232, United States

  • Neurology

    Frisco, Texas, 75035, United States

  • Neurology

    Houston, Texas, 77030, United States

  • Neurology

    Round Rock, Texas, 78681, United States

  • Neurology

    Kirkland, Washington, 98034, United States

  • Neurology

    Madison, Wisconsin, 53705, United States

  • Neurology

    Milwaukee, Wisconsin, 53226, United States

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