Trial Outcomes & Findings for Atomoxetine for Freezing of Gait in Parkinson's Disease (NCT NCT03651856)
NCT ID: NCT03651856
Last Updated: 2018-11-28
Results Overview
Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
10 participants
Primary outcome timeframe
week 8
Results posted on
2018-11-28
Participant Flow
Participant milestones
| Measure |
Atomoxetine
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 Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Atomoxetine for Freezing of Gait in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Atomoxetine
n=10 Participants
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
|
|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 3.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Count of Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 8Evaluate the safety of Atomoxetine 40mg bid in PD patients with FOG (Freezing of Gait)
Outcome measures
| Measure |
Atomoxetine
n=10 Participants
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
|
|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
Increase in Creatine
|
3 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Worsening Fog (Freezing of Gait)
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Diarrhea
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Worsening Dyskinesia
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Nausea
|
1 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events
Mild Jitters
|
1 Participants
|
Adverse Events
Atomoxetine
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Atomoxetine
n=10 participants at risk
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
|
|---|---|
|
Blood and lymphatic system disorders
Increase in Creatine
|
30.0%
3/10 • Number of events 3
|
|
Nervous system disorders
Worsening Fog (Freezing of Gait)
|
10.0%
1/10 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Worsening Dyskinesia
|
10.0%
1/10 • Number of events 1
|
|
General disorders
Nausea
|
10.0%
1/10 • Number of events 1
|
|
Nervous system disorders
Mild Jitters
|
10.0%
1/10 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place