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Study of Atomoxetine to Reduce Freezing of Gait in Patients with Parkinson's Disease During OFF-State

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Parkinson's disease, specifically examining a symptom called freezing of gait - a temporary inability to move while walking that commonly affects people with this condition. The research investigates the effectiveness of a medication called atomoxetine, which affects the brain's alertness system, in reducing these freezing episodes.

The study compares Atomoxetine Aurobindo hard capsules (40 mg) with a placebo. The medication or placebo will be taken orally. The main purpose is to determine whether atomoxetine can reduce the amount of time patients experience freezing episodes, particularly when their regular Parkinson's medication is wearing off.

During the study, participants will undergo various walking tests to measure how the medication affects their walking ability and freezing episodes. The research will also examine how the medication influences brain activity patterns. The medication being tested is provided in a modified package to ensure neither the patient nor the researcher knows whether they are receiving the actual medication or placebo during the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication period

    You will receive either atomoxetine (40 mg capsules) or a placebo (inactive capsule) to take by mouth

    The capsules should be taken according to the provided schedule while continuing your regular Parkinson's disease medication

  2. Step 2

    OFF-state assessment

    You will be evaluated in an OFF-state (when your regular Parkinson's medication effect has worn off)

    The assessment includes performing specific walking tasks designed to trigger freezing of gait (temporary inability to move while walking)

    The percentage of time spent frozen during these tasks will be measured

  3. Step 3

    ON-state assessment

    You will be evaluated in an ON-state (when your regular Parkinson's medication is working)

    The same walking tasks will be performed to measure freezing of gait

    Brain network activity will be monitored during this assessment

  4. Step 4

    Medication switch period

    After completing the first assessment period, you will switch to the other treatment (either atomoxetine or placebo)

    The same series of assessments will be repeated

  5. Step 5

    Final evaluation

    The study will compare how atomoxetine and placebo affect freezing of gait in both medication states

    Brain network patterns will be analyzed to understand how the medication affects brain function

Who can join the trial?

7 criteria

  • Must be at least 18 years old, both men and women can participate
  • Must have been diagnosed with Parkinson's disease according to specific medical criteria
  • Must be on a stable dopaminergic treatment (medications that increase dopamine levels in the brain) for at least 4 weeks before starting the study
  • Must experience freezing of gait (temporary inability to move feet while walking) on a daily basis
  • Must be able to walk 10 meters without assistance when medication is working (during "ON" state)
  • Must be able to provide written informed consent (formal agreement to participate in the study)
  • Must be willing and able to complete all required study tests and assessments

Who cannot join the trial?

14 criteria

  • Having other neurological conditions besides Parkinson's disease
  • Current or recent use of medications that interact with atomoxetine (the study drug)
  • Severe heart conditions or uncontrolled high blood pressure
  • History of severe depression or other major psychiatric disorders
  • Liver disease or abnormal liver function
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Inability to complete study assessments or follow study procedures
  • History of substance abuse within the past year
  • Allergic reactions to atomoxetine or similar medications
  • Severe kidney problems
  • Use of MAO inhibitors (a type of antidepressant) within 14 days before the study
  • Narrow-angle glaucoma (an eye condition with increased pressure inside the eye)
  • Unable to temporarily stop taking Parkinson's medications for study assessments
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Investigated drugs

Atomoxetine is a medication that works by increasing the levels of norepinephrine (a natural chemical) in the brain. It is typically used to treat attention deficit hyperactivity disorder (ADHD), but in this trial, it is being studied for its potential to help reduce freezing of gait (a movement problem where people temporarily feel stuck while walking) in people with Parkinson's disease. The medication works by affecting the noradrenergic system, which is involved in arousal and attention.

What is already known about the treatment

Atomoxetine - A selective norepinephrine reuptake inhibitor administered orally in capsule form, primarily used in the treatment of attention deficit hyperactivity disorder (ADHD) but currently being studied for potential benefits in Parkinson's disease, particularly for freezing of gait symptoms. The medication works by increasing the levels of norepinephrine in the brain by blocking its reuptake into nerve cells, which may help improve cognitive function and motor control. In clinical trials for Parkinson's disease, researchers are investigating its effectiveness in reducing freezing of gait episodes during the "off" periods when standard Parkinson's medications are less effective, representing a novel therapeutic approach for this challenging symptom.

Investigated diseases

Parkinson's disease - A progressive neurological disorder that affects movement and motor control. The condition develops when nerve cells in a specific part of the brain begin to break down and die, leading to decreased production of dopamine. The disease typically starts gradually with mild symptoms that worsen over time, including tremors, stiffness, and balance problems. People with Parkinson's may experience slowed movement (bradykinesia), rigid muscles, impaired posture, and changes in speech. The condition can also cause freezing of gait (FOG), where patients temporarily feel as if their feet are glued to the ground during walking.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516756-18-00Protocol code116130Estimated enrolment60 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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