NCT07316296RecruitingPhase 3
Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
Source: ClinicalTrials.gov · Last updated 27 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 16 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Radboud University Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT07316296
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 60
- From 1 Jan 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current and/or previous (within 3 months) participation in a clinical trial;
- Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine);
Other illness
- Severe cognitive impairment hampering the ability to comply with the study protocol;
- 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;
- (History of) pheochromocytoma;
- Known hypersensitivity to atomoxetine.
Lab values
- 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;
Other
- 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);
- Active psychosis that would impact the ability to comply with the study protocol;
- Narrow angle glaucoma;
- Use of noradrenergic agents;
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboudumc Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.