Parkinson's Disease study: Atomoxetine
Official title Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
ClinicalTrials.gov ID: NCT07316296
What this study is testing
What is Atomoxetine?
Atomoxetine is an investigational medicine, taken by mouth, being studied as a potential treatment for parkinson's disease (pd).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out whether atomoxetine reduces how often or how severe freezing of gait is, and how the brain chemical noradrenaline is involved.
- Who it's for
- Adults with Parkinson's disease who experience freezing of gait.
- What's involved
- Participants will take atomoxetine or a placebo, have walking tests, undergo MRI scans, and fill out questionnaires about anxiety, stress, and quality of life.
- Time commitment
- The trial lasts for the study period with several site visits for measurements, medication, walking assessments, MRI, and questionnaires.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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;
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Nijmegen, Gelderland, Netherlands
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nijmegen, Gelderland, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.