A Phase 4 interventional study of Northera and Placebo Oral Tablet in Parkinson Disease, Fatigue and Parkinsonism, sponsored by The Cooper Health System. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-23.
Sponsored by The Cooper Health System · Phase 4, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled trial comparing droxidopa to placebo for fatigue in Parkinson's Disease. The primary outcome measure is change in the Parkinson's Disease Fatigue Scale, a 16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization. Secondary outcomes are the PDQ-39, a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being, and the Epworth Sleepiness Scale, a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep. There will be a screening visit (SC), baseline visit (BL), 2 clinic visits at 6 and 12 weeks (V01, V02), and telephone contact at 4 weeks and 8 weeks (T1, T2). In-person visits will include review of informed consent, concomitant medication review, adverse event review, pill counts, vital signs (including supine blood pressure), and outcome measurements. Telephone visits will include review of informed consent, concomitant medication review, and adverse event review.
4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.
This study's enrollment of 1 is below the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →The Cooper Health System is the lead sponsor of 67 studies on the registry; 18 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active group started 100 mg TID, increased by 100 mg per interval (i.e. 100 TID) every 2 days till on 600 TID, or until intolerable dose is achieved at which time the next highest dose will be maintained (increments of 100 TID will be used).
Drug: Northera
Dosing regimen identical to active group
Drug: Placebo Oral Tablet
Also known as: Droxidopa
Parkinson's Disease Fatigue Scale
16-item scale that measures the physical effects of fatigue as well as the impact of fatigue on daily functioning and activities, including socialization
Time frame: Week 12
PDQ-39
a 39-item self-report questionnaire assessing Parkinson's disease-specific health related quality over the last month in 8 different dimensions of function and well-being
Time frame: Week 12
Epworth Sleepiness Scale
a questionnaire querying 8 situations for which the subject will rate the likelihood of falling asleep
Time frame: Week 12
This study is terminated, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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