Atomoxetine for Freezing of Gait in Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03651856
• Date of registration: 02/07/2018
• Prospective Registration: No
• Primary sponsor: Medical University of South Carolina
• Public title: Atomoxetine for Freezing of Gait in Parkinson's Disease ATMFOG
• Scientific title: A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
• Date of first enrolment: January 2013
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03651856
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Gonzalo J Revuelta, DO
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Idiopathic Parkinson's Disease according to UK Brain Bank Criteria, Hoehn
and Yahr stage 2-4

2. A positive response to item 14 of the UPDRS, part 2.

3. Age range 18-80

4. Ability to walk a minimum of 20 feet without assistive device and with one observed
freezing episode which may be triggered by visual cue

5. Letter of medical clearance by primary care physician dated within preceding 2 months
of subject's initial active study visit.

6. Stable on PD medications for = 3 months

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Exclusion Criteria:

1. Intolerance to drug class

2. Mini-Mental Status Examination <26/30

3. No observable episodes of freezing of gait despite common visual cues

4. Not on stable PD medications for 3 months

5. Subjects who whose gait disturbance is due to other conditions not related to PD or
FOG.

6. Current use of monoamine oxidase inhibitor (MAO-I)

7. Hypersensitivity to drug class

8. Narrow angle glaucoma

9. Pheochromocytoma

10. 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).

11. Patients with uncontrolled hypertension.

12. Patients with a history of symptomatic tachyarrhythmias.

13. Presence of uncontrolled depression and suicidal ideation.

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Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Freezing of Gait

Intervention(s)

Drug: ATM FOG in PD

Primary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events [Time Frame: week 8]

Secondary ID(s)

Pro00014009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 28/11/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03651856