The effect of atomoxetine efficacy on freezing of gait in patient with Parkinson’s disease: a double-blinded randomized clinical trial

Introduction: Freezing of gait (FOG) is a debilitating symptom experienced by many individuals with Parkinson’s disease, characterized by an abrupt and transient inability to initiate or continue locomotion. Despite extensive research, effective pharmacological interventions targeting FOG remain elusive. Atomoxetine, a selective norepinephrine reuptake inhibitor, has shown promise in alleviating FOG in small-scale studies. However, the efficacy of atomoxetine in larger cohorts remains underexplored. Objectives: This study aims to assess the impact of atomoxetine on Parkinson’s disease-related FOG in a larger study population than currently reported in the literature. Patients and Methods: This randomized clinical trial was performed in Golestan Hospital, Ahvaz, Iran, in 2022. The participants were divided into group A comprising 16 patients subjected to atomoxetine treatment, and group B consisting of 16 patients administered a placebo. Three scheduled visits were conducted. Freezing of Gait Questionnaire (FOGQ) scores was documented during each visit. Results: The mean age of all participants was 62.4 ± 8.3 years, with no significant intergroup age disparity and no statistically significant gender-based distinctions between the two groups. The average disease duration in the atomoxetine group was 8.2 ± 3.1 years, while in the placebo group, it was 7.2 ± 3.4 years, with no significant divergence between the two groups. The study findings indicated no significant distinction in FOGQ scores between the treatment and placebo groups. Conclusion: Though atomoxetine did not significantly improve improvement in freezing of the gait of studied patients with Parkinson’s disease, it may cause a modest improvement in the gait freezing of some patients. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical Trials (identifier: IRCT20211008052695N1; https://irct.behdasht.gov.ir/trial/59643, ethical code; #IR.AJUMS.HGOLESTAN. REC.1400.026).