Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach

Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach (NCT07316296) is a Phase 3 interventional studying Parkinson's Disease (PD) and Freezing of Gait, sponsored by Radboud University Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

The goal of this clinical trial is to learn if the medication atomoxetine can reduce freezing of gait in people with Parkinson's disease. The main questions it aims to answer is: Does atomoxetine reduce the frequency or severity of freezing of gait? What role does noradrenaline play in freezing of gait? Researchers will compare atomoxetine to a placebo to see if atomoxetine can improve freezing of gait in people with Parkinson's disease. Participants will: Visit the study site for measurements Take atomoxetine or placebo Perform walking assessments and undergo MRI Complete questionnaires about anxiety, stress, and quality of life

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Parkinson's Disease (PD), Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Parkinson's Disease (PD) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Aged 18 years or older; - Diagnosis of idiopathic PD according to MDS Diagnostic Criteria; - Stabilised on optimal dopaminergic PD treatment for a minimum of four weeks prior to the baseline visit (Visit 1) and for the duration of the trial; - Presence of FOG symptoms on a daily basis; - Ability to walk for 10-meters unaided in the dopaminergic ON-state; - Ability to provide written willing to sign a consent form in accordance with ICH-GCP and local regulations; - Willing and able to undergo all clinical trial assessments. Who Should NOT Join This Trial: - Current and/or previous (within 3 months) participation in a clinical trial; - Any contra-indications for undergoing MRI-scanning (e.g. claustrophobia or metal parts within the body such as DBS, an infusion pump or a pacemaker); - Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments); - Severe cognitive impairment hampering the ability to comply with the study protocol; - Active psychosis that would impact the ability to comply with the study protocol; - Severe cardiovascular disorders: severe hypertension (Sustained (Sitting) hypertension of ≥180 mmHg systolic or ≥110 mmHg diastolic, defined by the average of three observations, each at least 3 minutes apart, with the participant having assumed the required position for at least 3 minutes), heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, long QT interval syndrome (QTc \> 500ms Bazett-formula) and channelopathies that in the opinion of the study PI would significantly compromise participant safety; - Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke; - Hepatic or renal insufficiency that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate; - Narrow angle glaucoma; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Aged 18 years or older; * Diagnosis of idiopathic PD according to MDS Diagnostic Criteria; * Stabilised on optimal dopaminergic PD treatment for a minimum of four weeks prior to the baseline visit (Visit 1) and for the duration of the trial; * Presence of FOG symptoms on a daily basis; * Ability to walk for 10-meters unaided in the dopaminergic ON-state; * Ability to provide written informed consent in accordance with ICH-GCP and local regulations; * Willing and able to undergo all clinical trial assessments. Exclusion Criteria: * Current and/or previous (within 3 months) participation in a clinical trial; * Any contra-indications for undergoing MRI-scanning (e.g. claustrophobia or metal parts within the body such as DBS, an infusion pump or a pacemaker); * Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments); * Severe cognitive impairment hampering the ability to comply with the study protocol; * Active psychosis that would impact the ability to comply with the study protocol; * Severe cardiovascular disorders: severe hypertension (Sustained (Sitting) hypertension of ≥180 mmHg systolic or ≥110 mmHg diastolic, defined by the average of three observations, each at least 3 minutes apart, with the participant having assumed the required position for at least 3 minutes), heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias, long QT interval syndrome (QTc \> 500ms Bazett-formula) and channelopathies that in the opinion of the study PI would significantly compromise participant safety; * Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke; * Hepatic or renal insufficiency that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate; * Narrow angle glaucoma; * (History of) pheochromocytoma; * Use of noradrenergic agents; * Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine); * Use of high dose salbutamol (or other beta2 agonists) that in the opinion of the Principal Investigator would impact on the ability of the participant to safely participate; * Pregnancy and/or breastfeeding; * Known hypersensitivity to atomoxetine.

Treatments Being Tested

DRUG

Atomoxetine

Single dose, 40mg atomoxetine, capsule

DRUG

Placebo

Single dose, placebo (microcrystalline cellulose), capsule

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Radboudumc

Nijmegen, Gelderland, Netherlands

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07316296), the sponsor (Radboud University Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07316296 clinical trial studying?

Who can participate in NCT07316296?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07316296?

Contact information for this trial may be available directly on the ClinicalTrials.gov record. Click "View on ClinicalTrials.gov" in the sidebar for the official source. Always discuss any potential trial with your doctor before contacting the study site.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07316296. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07316296. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.