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

Ki vehet részt

• 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

Ki nem vehet részt

• Current and/or previous (within 3 months) participation in a clinical trial
• Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine)
• 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
• 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
• 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