|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 September 2022 |
|
Main ID: |
NCT03229174 |
|
Date of registration:
|
21/04/2017 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Brain Perfusion & Oxygenation in Parkinson's Disease With NOH
|
|
Scientific title:
|
Evaluation of Brain Perfusion and Oxygenation in PD Patients With Neurogenic Orthostatic Hypotension: 4 Week Comparison of Droxidopa Versus Placebo |
|
Date of first enrolment:
|
August 23, 2018 |
|
Target sample size:
|
17 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03229174 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 4
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
William Ondo, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Methodist Hospital Research Institute |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Idiopathic Parkinson's disease patients with orthostatic hypotension (Systolic Blood
Pressure drop of > 20 mm hg or Diastolic Blood Pressure drop of >10 mm hg measured at
some point) within a month of inclusion.
Exclusion Criteria:
- Age >85
- Concurrent use of Midodrine
- Medical conditions that in the opinion of the investigator, might not allow for same
completion of the study i.e. unstable angina, neoplasm, etc
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Neurogenic Orthostatic Hypotension
|
|
Parkinson Disease
|
|
Intervention(s)
|
|
Drug: Droxidopa
|
|
Drug: Placebo
|
|
Primary Outcome(s)
|
|
Brain oxygenation
[Time Frame: 8 weeks]
|
|
Cerebral perfusion
[Time Frame: 8 weeks]
|
|
Secondary Outcome(s)
|
|
R-R variability
[Time Frame: 8 weeks]
|
|
Arteriole Blood Pressure
[Time Frame: 8 weeks]
|
|
Assessment of gait and falls
[Time Frame: 8 weeks]
|
|
Assessment of Parkinson's disease symptoms
[Time Frame: 8 weeks]
|
|
Orthostatic hypotension
[Time Frame: 8 weeks]
|
|
Secondary ID(s)
|
|
Pro00013931
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|