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NCT01676103 · ClinicalTrials.gov registry record · Phase 1
The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease
A Phase 1 study, sponsored by New York Institute of Technology.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01676103: Completed Phase 1 study, sponsored by New York Institute of Technology.
NCT01676103 is a Phase 1 study that has completed, run by New York Institute of Technology. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01676103, a Phase 1 study, has completed, sponsored by New York Institute of Technology.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The objective of this experiment is: * Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD. * Secondary: To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on HR, BP, and norepinephrine responses during acute exercise stress. Orthostatic hypotension and autonomic abnormalities are a common problem for individuals who suffer from PD, especially as it leads to lightheadedness and falling. For those affected, it can drastically reduce quality of life. It has been hypothesized that tyrosine may impact upon individuals suffering from PD. There is ample evidence in animal models that supports our theory; however there is no clinical evidence of the impact tyrosine supplementation may have in PD patients who suffer from orthostatic hypotension and blunted BP and HR responses. Positive findings that supplemental tyrosine increases BP and HR in people with PD during daily activities such as standing up from a chair and walking can lead to new therapies to improve Parkinsonian orthostatic hypotension. Hypothesis We will test the hypothesis that symptomatic individuals with PD on dopamine therapy who suffer from orthostatic hypotension and blunted HR and BP responses will improve after tyrosine supplementation.
Primary Outcome
Orthostatic Blood Pressure Testing: Subjects will sit and rest for 10 minutes. Blood pressure will be taken in this resting position after the 10 minutes. Subjects will then stand upright for 3 minutes. Blood pressure will be taken every minute for those 3 minutes. A drop in systolic BP of 20 mmHg and a 10 mmHg in diastolic drop within these 3 minutes indicates orthostatic hypotension according to the American Academy of Neurology. Blood Samples: Norepinephrine and tyrosine will all be examin
Interventions
- DIETARY_SUPPLEMENT Tyrosine
- OTHER Placebo Comparator:Sugar Pill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT01676103 record still lists
NCT01676103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Tyrosine is the first listed.
NCT01676103 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01676103 about?
NCT01676103 is a clinical study titled "The Effects of Supplementing Tyrosine on Blood Pressure in Parkinson's Disease". The objective of this experiment is: * Primary: To determine the effects of tyrosine supplementation on orthostatic hypotension in people with PD. * Secondary: To determine the effects of tyrosine supplementation in people with PD with autonomic insufficiency on HR, BP, and norepinephrine responses...
What is the current status of trial NCT01676103?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2012-09. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01676103?
The interventions under investigation include: Tyrosine (DIETARY_SUPPLEMENT), Placebo Comparator:Sugar Pill (OTHER).
Who is sponsoring clinical trial NCT01676103?
This trial is sponsored by New York Institute of Technology, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01676103's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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