Atomoxetine reduces freezing of gait
- 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
- Atomoxetine reduces freezing of gait
- 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
Plain-Language Summary
The goal is to reduce freezing of gait in people with Parkinson's by boosting the brain's noradrenergic arousal system so starting and continuing to walk becomes easier in daily life. The approach uses atomoxetine, a norepinephrine reuptake inhibitor that raises brain noradrenaline to improve attention and motor initiation for walking, given versus placebo and meant to be added on to stable dopaminergic therapy like levodopa; people taking other noradrenergic drugs or CYP2D6 inhibitors are excluded because of interaction and safety risks. The trial looks for adults 18 and older with idiopathic PD who have daily freezing, are on stable dopaminergic treatment for at least four weeks, can walk 10 meters unaided in the ON state, and can undergo MRI, so those with DBS, certain heart or eye conditions, severe cognitive or psychotic symptoms, or current use of excluded medications would not qualify.
Locations
- Radboudumc, Nijmegen, Gelderland, Netherlands
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Atomoxetine. The goal is to reduce freezing of gait in people with Parkinson's by boosting the brain's noradrenergic arousal system so starting and continuing to walk becomes easier in daily life. The approach uses atomoxetine, a norepinephrine reuptake inhibitor that raises brain noradrenaline to improve attention and motor initiation for walking, given versus placebo and meant to be added on to stable dopaminergic therapy like levodopa; people taking other noradrenergic drugs or CYP2D6 inhibitors are excluded because of interaction and safety risks. The trial looks for adults 18 and older with idiopathic PD who have daily freezing, are on stable dopaminergic treatment for at least four weeks, can walk 10 meters unaided in the ON state, and can undergo MRI, so those with DBS, certain heart or eye conditions, severe cognitive or psychotic symptoms, or current use of excluded medications would not qualify.
- 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?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 3 trial is estimated to last approximately 1 year and 6 months.