ATMFOG: Atomoxetine for Freezing of Gait in Parkinson's Disease

• Sponsor: Medical University of South Carolina (Other)
• Overall Status: Completed
• CT.gov ID: NCT03651856
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 13
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease; Freezing of Gait	Drug: ATM FOG in PD	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's Disease
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Feb 1, 2014
• Actual Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atomoxetine Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off	Drug: ATM FOG in PD; open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment Emergent Adverse Events [week 8]

   Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

• Medical University of South Carolina

Investigators

• Principal Investigator: Gonzalo J Revuelta, DO, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03651856
• Other Study ID Numbers: Pro00014009
• First Posted: Aug 29, 2018
• Last Update Posted: Nov 28, 2018
• Last Verified: Nov 1, 2018

• Additional relevant MeSH terms: Parkinson Disease

Study Results

Participant Flow

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Overall Participants	10
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.1 (3.5)
Sex: Female, Male (Count of Participants)
Female	2 20%
Male	8 80%
Region of Enrollment (Count of Participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment Emergent Adverse Events
Description	Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
Measure Participants	10
Increase in Creatine	3 30%
Worsening Fog (Freezing of Gait)	1 10%
Diarrhea	1 10%
Worsening Dyskinesia	1 10%
Nausea	1 10%
Mild Jitters	1 10%

Adverse Events

Arm/Group Title	Atomoxetine
Arm/Group Description	Atomoxetine 40mg daily for 2 weeks uptitration Atomoxetine 40mg BID for 4 weeks Atomoxetine 40mg daily for 1 week weaning off ATM FOG in PD: open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
All Cause Mortality
	Atomoxetine
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Atomoxetine
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Atomoxetine
	Affected / at Risk (%)	# Events
Total	8/10 (80%)
Blood and lymphatic system disorders
Increase in Creatine	3/10 (30%)	3
Gastrointestinal disorders
Diarrhea	1/10 (10%)	1
General disorders
Nausea	1/10 (10%)	1
Nervous system disorders
Worsening Fog (Freezing of Gait)	1/10 (10%)	1
Worsening Dyskinesia	1/10 (10%)	1
Mild Jitters	1/10 (10%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.