drugset / Trial / NCT02857244

A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients

NCT02857244

Phase 2 Withdrawn University of Chicago
NaSingle-groupOpen-labelTreatment

Summary

The study team proposes to treat Parkinson's patients with gait difficulty with multidisciplinary approach of medications. Single medication treatment, such as the use of cholinergic-boosting anti-dementia medication targeting cholinergic deficiency to improve executive dysfunction and attention deficit, or the use of medication boosting the norepinephrine system, have not proven effective so far in treating the gait difficulty. Anti-anxiety medications, particularly the SNRI (serotonin and norepinephrine reuptake inhibitor) medications, which also ameliorate the norepinephrinergic deficiency, have not been studied except for one successful case report using duloxetine to treat primary progressive freezing of gait. Targeting multiple mechanisms at same time, such as the combination of a SNRI antianxiety medication (also boosting the norepinephrine system, such as duloxetine) with an anti-dementia medication correcting the cholinergic deficiency (such as donepezil), or targeting a new mechanism, such as the use of anti-GABAergic medication targeting the area responsible for gait and sleep cycle (pedunculopontine nucleus area, PPNa) should be tried. Therefore, a collaboration of multidisciplinary teams among the neurology movement disorder team and cognition and sleep team, and psychiatry team is essential, which has not been tried before in studying and treating the challenging gait difficulty in Parkinson patients.

Timeline

Start
2016-11
Primary completion
2017-11
Completion
2017-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Donepezil Small molecule 10 mg
Subject Duloxetine Small molecule 120 mg
Subject Modafinil Small molecule 200 mg

Indications