---
title: Atomoxetine reduces freezing of gait
nct_id: NCT07316296
phase: PHASE3
status: RECRUITING
sponsor: Radboud University Medical Center
study_type: INTERVENTIONAL
canonical_url: "https://parkinsonspathways.com/trial/NCT07316296"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07316296"
last_fetched: "2026-05-10T14:01:44.116Z"
source: "Parkinson's Pathways (curated)"
---
# Atomoxetine reduces freezing of gait

**Goal (in five words):** Atomoxetine reduces freezing of gait

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

**Trial ID:** [NCT07316296](https://clinicaltrials.gov/study/NCT07316296)

## Key Facts

- **Phase:** PHASE3
- **Status:** RECRUITING
- **Study Type:** INTERVENTIONAL
- **Sponsor:** Radboud University Medical Center
- **Target Enrollment:** 60 participants
- **Start Date:** 2026-01-01
- **Completion Date:** 2027-07-01
- **Conditions:** Parkinson's Disease (PD), Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease
- **Interventions:** Atomoxetine, Placebo
- **Intervention Types:** DRUG

## Summary For Families

The goal is to reduce freezing of gait in people with Parkinson's by boosting the brain's noradrenergic arousal system so starting and continuing to walk becomes easier in daily life. The approach uses atomoxetine, a norepinephrine reuptake inhibitor that raises brain noradrenaline to improve attention and motor initiation for walking, given versus placebo and meant to be added on to stable dopaminergic therapy like levodopa; people taking other noradrenergic drugs or CYP2D6 inhibitors are excluded because of interaction and safety risks. The trial looks for adults 18 and older with idiopathic PD who have daily freezing, are on stable dopaminergic treatment for at least four weeks, can walk 10 meters unaided in the ON state, and can undergo MRI, so those with DBS, certain heart or eye conditions, severe cognitive or psychotic symptoms, or current use of excluded medications would not qualify.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

### Full Criteria

```
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.
```

## Locations (1)

- Radboudumc, Nijmegen, Gelderland, Netherlands _(51.8425, 5.8528)_
  - Franka Goossens — (CONTACT) — +31243668426 — franka.goossens@radboudumc.nl

---

*Canonical: https://parkinsonspathways.com/trial/NCT07316296*  
*HTML version: https://parkinsonspathways.com/trial/NCT07316296*  
*Source data: https://clinicaltrials.gov/study/NCT07316296*