Actively Recruiting
Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
Led by Radboud University Medical Center · Updated on 2026-02-27
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Radboud University Medical Center
Lead Sponsor
U
University of Waterloo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosis of idiopathic Parkinson's disease according to MDS Diagnostic Criteria
- Stabilised on optimal dopaminergic Parkinson's disease treatment for at least four weeks before baseline and throughout the trial
- Experience freezing of gait symptoms daily
- Able to walk 10 meters unaided during dopaminergic ON-state
- Able to provide written informed consent according to ICH-GCP and local regulations
- Willing and able to complete all clinical trial assessments
You will not qualify if you...
- Current or recent participation (within 3 months) in another clinical trial
- Contraindications for MRI scanning such as claustrophobia or metal implants including DBS, infusion pump, or pacemaker
- Co-morbidities significantly affecting walking ability (e.g., orthopedic or rheumatological conditions)
- Severe cognitive impairment that prevents study compliance
- Active psychosis impacting study compliance
- Severe cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, significant congenital heart disease, cardiomyopathies, myocardial infarction, life-threatening arrhythmias, long QT syndrome, or channelopathies deemed unsafe by the investigator
- Severe cerebrovascular disorders such as cerebral aneurysm or recent/significant stroke
- Hepatic or renal insufficiency that affects safe participation
- Narrow angle glaucoma
- History of pheochromocytoma
- Use of noradrenergic agents
- Use of CYP2D6 inhibitors including SSRIs, quinidine, or terbinafine
- Use of high dose beta2 agonists like salbutamol if deemed unsafe by the investigator
- Pregnancy or breastfeeding
- Known allergy to atomoxetine
AI-Screening
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Trial Site Locations
Total: 1 location
1
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525 GA
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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