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Atomoxetine to Reduce Freezing of Gait in Parkinson's Disease
NCT07316296Phase 3
Key facts
- Status
- Recruiting
- Start
- Jan 2026
- Primary completion
- Jul 2027
- Countries
- 1
- Sponsor
- Radboud University Medical Center
- Modality
- Small Molecules
- Drugs
- atomoxetine
- Conditions
- Parkinson's disease (PD)Freezing of gait (FOG)
01
Overview
Phase 3, randomised, double-blind trial of atomoxetine in Parkinson's disease (PD) and Freezing of gait (FOG) (2 arms), sponsored by Radboud University Medical Center. Primary endpoint: Percentage of time frozen in the dopaminergic OFF-state at 2 weeks. Started Jan 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Atomoxetine -> Placebo
Atomoxetine in visit 2 and placebo in visit 3
Placebo -> Atomoxetine
Placebo in visit 2 and atomoxetine in visit 3
03
Who it enrols
Adults with idiopathic Parkinson's disease, stabilized on dopaminergic treatment, experiencing daily freezing of gait symptoms, and able to walk 10 meters unaided in the ON-state. Excludes patients with severe cardiovascular, cerebrovascular, hepatic, or renal disorders, active psychosis, severe cognitive impairment, or those taking contraindicated medications.
04
Endpoints
Primary
Percentage of time frozen in the dopaminergic OFF-state
Secondary
Percentage of time frozen in the dopaminergic ON-state
Brain network integration-segregation coefficient
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