Phase 3 N=10 Treatment

Atomoxetine for Freezing of Gait in Parkinson's Disease

Parkinson's Disease · Freezing of Gait

Bottom Line

View on ClinicalTrials.gov: NCT03651856 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events — 3; 1; 1; 1 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ATM FOG in PD (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Feb 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment Emergent Adverse Events	3; 1; 1; 1; 1; 1	—

Summary

Subjects are being asked to participate in this study to determine the safety and effectiveness of a drug called atomoxetine in the treatment of freezing of gait for Parkinson's Disease patients. Atomoxetine (ATM) is an approved drug currently on the market for the treatment of attention deficit. It works to increase the amount of norepinephrine (a chemical in the brain that helps keep us awake and alert) in our brain. ATM has not been approved by the Food and Drug Administration (FDA) to be used in the treatment of PD, but has been found to be well tolerated in this patient population.

Eligibility Criteria

Inclusion Criteria

Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn and Yahr stage 2-4
A positive response to item 14 of the UPDRS, part 2.
Age range 18-80
Ability to walk a minimum of 20 feet without assistive device and with one observed freezing episode which may be triggered by visual cue
Letter of medical clearance by primary care physician dated within preceding 2 months of subject's initial active study visit.
Stable on PD medications for ≥ 3 months

Exclusion Criteria

Intolerance to drug class
Mini-Mental Status Examination <26/30
No observable episodes of freezing of gait despite common visual cues
Not on stable PD medications for 3 months
Subjects who whose gait disturbance is due to other conditions not related to PD or FOG.
Current use of monoamine oxidase inhibitor (MAO-I)
Hypersensitivity to drug class
Narrow angle glaucoma
Pheochromocytoma
Severe cardiovascular disorders, i.e. patients with pre-existing conditions that would be expected to deteriorate if their heart rate or blood pressure were to increase in a clinically significant manner (e.g. 15-20 mmHg increase in blood pressure or 20 beats per minute in heart rate).
Patients with uncontrolled hypertension.
Patients with a history of symptomatic tachyarrhythmias.
Presence of uncontrolled depression and suicidal ideation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03651856). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.