Status:
COMPLETED
Lundbeck TOMs Orthostatic Hypotension
Lead Sponsor:
Alberto Espay, MD, MSc
Collaborating Sponsors:
Lundbeck LLC
Conditions:
Orthostatic Hypotension
Idiopathic Parkinson Disease
Eligibility:
All Genders
30-80 years
Phase:
PHASE4
Brief Summary
Orthostatic hypotension (OH), which consists in a significant reduction in blood pressure levels upon standing from a seated position, may affect approximately one in three patients with Parkinson's d...
Eligibility Criteria
Inclusion
- Diagnosis of idiopathic Parkinson's Disease, meeting UK Brain Bank criteria for at least 3 years
- Hoehn and Yahr (H\&Y) stage I-III
- Age between 30 and 80 years old (both inclusive)
- Stable dosage of dopaminergic medications for at least 4 weeks
- Orthostatic Hypotension, defined as a fall in systolic BP ≥ 20 mmHg or diastolic BP ≥ 10 mmHg within 3 minutes of standing
- Willingness and ability to comply with scheduled visits
Exclusion
- Diabetes mellitus or other diseases potentially associated with autonomic dysfunction
- Treatment with antihypertensive drugs or with alpha-adrenergic antagonists
- Cognitive impairment, defined as a score \< 24 at the Montreal Cognitive Assessment (MoCA)
- Any atypical signs lowering the diagnostic certainty for PD
- Lack of postural reflex defined as a score \> 2 at the MDS-UPDRS item 3.12 (recover at the pull test)
- Severe levodopa induced dyskinesia, defined as an MDS-UPDRS item 4.2 \> 2 (functional impact of dyskinesia)
Key Trial Info
Start Date :
February 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04510922
Start Date
February 11 2019
End Date
December 31 2020
Last Update
September 26 2022
Active Locations (1)
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1
University of Cincinnati
Cincinnati, Ohio, United States, 45219