Atomoxetine for Parkinson's (NCT07316296)
Reduce freezing of gait episodes
- Trial ID
- NCT07316296
- Official Title
- Pharmacologically Modulating the Noradrenergic Arousal System to Reduce Freezing of Gait in Parkinson's Disease: a Multi-centre and Multi-modal Approach
- Goal
- Reduce freezing of gait episodes
- Phase
- PHASE3
- Status
- RECRUITING
- Sponsor
- Radboud University Medical Center
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson's Disease (PD), Freezing of Gait, Freezing of Gait Symptoms in Parkinson Disease
- Interventions
- Atomoxetine, Placebo
Summary For Families
Researchers are testing whether atomoxetine can reduce freezing of gait in people with Parkinson's and whether the brain chemical noradrenaline plays a role in those freezing episodes. Participants will take either atomoxetine or a placebo, do timed walking tests and brain scans, and complete questionnaires about anxiety, stress, and quality of life so investigators can compare effects on freezing and related symptoms. The trial is open to adults 18 and older with Parkinson's who have daily freezing, can walk 10 meters without help when their usual Parkinson's medicines are working, and who are on a stable dopamine-based treatment; people who cannot safely have a brain scan or who have major health issues are not eligible.
Locations
- Radboudumc, Nijmegen, Gelderland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Atomoxetine. Researchers are testing whether atomoxetine can reduce freezing of gait in people with Parkinson's and whether the brain chemical noradrenaline plays a role in those freezing episodes. Participants will take either atomoxetine or a placebo, do timed walking tests and brain scans, and complete questionnaires about anxiety, stress, and quality of life so investigators can compare effects on freezing and related symptoms. The trial is open to adults 18 and older with Parkinson's who have daily freezing, can walk 10 meters without help when their usual Parkinson's medicines are working, and who are on a stable dopamine-based treatment; people who cannot safely have a brain scan or who have major health issues are not eligible.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 6 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This is a crossover trial: instead of staying in one group, you move through a sequence of assignments, so you receive the active treatment during at least one period of the study. It also includes a placebo or sham phase, so you would be on that during another period. Ask the coordinator for the exact sequence and how long each phase lasts.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Questionnaires & surveys (non-invasive). Confirm the full schedule with the study coordinator.