NCT07316296 Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
| NCT ID | NCT07316296 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Radboud University Medical Center |
| Condition | Parkinson's Disease (PD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2026-01-01 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07316296 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson's Disease (PD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07316296 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT07316296 currently recruiting?
Yes, NCT07316296 is actively recruiting participants. Visit ClinicalTrials.gov or contact Radboud University Medical Center to inquire about joining.
Where is the NCT07316296 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands.
Who is sponsoring the NCT07316296 clinical trial?
NCT07316296 is sponsored by Radboud University Medical Center. The trial plans to enroll 60 participants.
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