ATOMOXETINE for Parkinson's disease

Inclusion criteria

• {"criterion_text":"- Male or female aged 18 years or older"}
• {"criterion_text":"- Diagnosis of idiopathic Parkinson's disease according to Movement Disorders Society Diagnostic Criteria"}
• {"criterion_text":"- Stabilised on optimal dopaminergic treatment for a minimum of four weeks prior to the baseline visit (Visit 1)"}
• {"criterion_text":"- Presence of freezing of gait symptoms on a daily basis"}
• {"criterion_text":"- Ability to walk for 10-meters unaided in the dopaminergic ON-state"}
• {"criterion_text":"- Ability to provide written informed consent in accordance with ICH-GCP and local regulations"}
• {"criterion_text":"- Willing and able to undergo all clinical trial assessments"}

Exclusion criteria

• {"criterion_text":"- Current and/or previous (within 3 months) participation in a clinical trial"}
• {"criterion_text":"- (History of) pheochromocytoma"}
• {"criterion_text":"- Use of noradrenergic agents"}
• {"criterion_text":"- Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine)"}
• {"criterion_text":"- Use of high dose salbutamol (or other beta2 agonists)"}
• {"criterion_text":"- Pregnancy and/or breastfeeding"}
• {"criterion_text":"- Known hypersensitivity to atomoxetine"}
• {"criterion_text":"- 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)"}
• {"criterion_text":"- Co-morbidity that significantly impacts ambulation (e.g. orthopaedic or rheumatological ailments)"}
• {"criterion_text":"- Severe cognitive impairment hampering the ability to comply with the study protocol"}
• {"criterion_text":"- Active psychosis that would impact the ability to comply with the study protocol"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke"}
• {"criterion_text":"- Hepatic or renal insufficiency"}
• {"criterion_text":"- Narrow angle glaucoma"}

Primary endpoints

• {"endpoint_text":"- The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic OFF-state.","definition_or_measurement_approach":"Percentage of time frozen measured during FOG-provoking gait tasks performed in the dopaminergic OFF-state; comparison of atomoxetine versus placebo."}

Secondary endpoints

• {"endpoint_text":"- The effect of atomoxetine vs. placebo on the percentage of time frozen during FOG-provoking gait tasks in the dopaminergic ON-state.","definition_or_measurement_approach":"Percentage of time frozen measured during FOG-provoking gait tasks performed in the dopaminergic ON-state; comparison of atomoxetine versus placebo."}
• {"endpoint_text":"- The effect of atomoxetine vs placebo on brain network topology, as calculated by the average integration/segregation coefficient.","definition_or_measurement_approach":"Brain network topology quantified by the average integration/segregation coefficient; comparison of atomoxetine versus placebo."}

Netherlands

Earliest CTIS Part Ii Submission Date

19-06-2025

Latest Decision Or Authorization Date

30-06-2025

Processing Time Days

11

Number Of Sites

2

Number Of Participants

20

Primary sponsor

Full Name

Stichting Radboud universitair medisch centrum

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands