Pharmacologically modulating the noradrenergic arousal system to reduce freezing of gait in Parkinson’s disease: a multi-center and multi-modal approach.
Key facts
- Where
- Nijmegen, HollandiaSee the 2 sites
- Phase
- 3. fázis
Where in Hollandia
- Radboud universitair medisch centrum StichtingNijmegen, HollandiaTaking people
- Radboud Universiteit NijmegenNijmegen, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stichting Radboud universitair medisch centrum
- Trial code
- EU 2024-516756-18-00
- Record updated
- 2026. május 13.
- Original description
To study the effect of atomoxetine FOG severity in the dopaminergic OFF-state.Read full original descriptionShow less
To study the effect of atomoxetine FOG severity in the dopaminergic OFF-state.
Inclusion: Male or female aged 18 years or older; Diagnosis of idiopathic Parkinson's disease according to Movement Disorders Society Diagnostic Criteria; Stabilised on optimal dopaminergic treatment for a minimum of four weeks prior to the baseline visit (Visit 1); Presence of freezing of gait 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: Current and/or previous (within 3 months) participation in a clinical trial; Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine); (History of) pheochromocytoma; Known hypersensitivity to atomoxetine; 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; 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 zettBa-formula) and channelopathies that would significantly compromise participant safety; Use of noradrenergic agents; Use of high dose salbutamol (or other beta2 agonists); Pregnancy and/or breastfeeding; 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.