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Pharmacologically modulating the noradrenergic arousal system to reduce freezing of gait in Parkinson’s disease: a multi-center and multi-modal approach.
EU CTIS ID: 2024-516756-18-00
What this study is testing
To study the effect of atomoxetine FOG severity in the dopaminergic OFF-state.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Current and/or previous (within 3 months) participation in a clinical trial
- (History of) pheochromocytoma
- Use of noradrenergic agents
- Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine)
- Use of high dose salbutamol (or other beta2 agonists)
- Pregnancy and/or breastfeeding
See the full eligibility criteria
- 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
- Current and/or previous (within 3 months) participation in a clinical trial
- (History of) pheochromocytoma
- Use of noradrenergic agents
- Use of CYP2D6 inhibitors (SSRIs, quinidine, terbinafine)
- Use of high dose salbutamol (or other beta2 agonists)
- Pregnancy and/or breastfeeding
- Known hypersensitivity to atomoxetine
- 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 zettBa-formula) and channelopathies that would significantly compromise participant safety
- Severe cerebrovascular disorders: cerebral aneurysm or recent/significant stroke
- Hepatic or renal insufficiency
- Narrow angle glaucoma
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.