Droxidopa + Pyridostigmine for Low Blood Pressure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of combining two medicines, Droxidopa and Pyridostigmine, to treat orthostatic hypotension—a condition where blood pressure drops upon standing, causing dizziness or fainting. Participants will receive various combinations of these treatments and placebos to determine the most effective option. It suits individuals diagnosed with orthostatic hypotension due to nervous system issues. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant medical advancements.
Do I need to stop my current medications for the trial?
You may need to stop certain medications that affect autonomic function 48 hours before testing, but this will be reviewed on a case-by-case basis. Some medications like fludrocortisone and stable doses of antidepressants are allowed. If stopping a medication is unsafe, the withdrawal period might be shortened.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Droxidopa is generally well-tolerated. In clinical studies, some participants experienced side effects such as increased blood pressure or mild high blood pressure, affecting about 2% to 7% of participants. Other side effects, like a slight slowing of the heart's electrical signals, were rare.
Pyridostigmine is also considered safe and manages a drop in blood pressure when standing, without causing high blood pressure when lying down.
The combination of Droxidopa and Pyridostigmine is currently under testing, with more safety information being gathered. Droxidopa has already received FDA approval for certain conditions, providing some reassurance about its safety. However, as this is a Phase 2 trial, the full safety profile of the combination is still under exploration.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they target low blood pressure with a novel combination approach. Droxidopa, a norepinephrine precursor, directly boosts blood pressure by increasing norepinephrine levels, which is different from many standard treatments like fludrocortisone or midodrine that work more indirectly. Pyridostigmine, on the other hand, inhibits the breakdown of acetylcholine, potentially enhancing communication between nerves and muscles, which can stabilize blood pressure. This dual-action strategy, combining Droxidopa and Pyridostigmine, offers a potential advantage by tackling low blood pressure from both a neurochemical and muscular angle, setting it apart from existing single-mechanism treatments.
What evidence suggests that this trial's treatments could be effective for orthostatic hypotension?
Research has shown that Droxidopa and Pyridostigmine can help increase blood pressure in individuals with orthostatic hypotension, a condition where blood pressure drops upon standing. In this trial, some participants will receive Droxidopa, which studies indicate effectively raises blood pressure and reduces symptoms like dizziness and lightheadedness. Others will receive Pyridostigmine, which can improve blood pressure without affecting it when lying down. The trial will also evaluate the combination of Droxidopa and Pyridostigmine, which might better manage low blood pressure symptoms. Early findings suggest this combination could be a promising option for those dealing with these symptoms.12456
Who Is on the Research Team?
Wolfgang Singer, M.D.
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals with orthostatic hypotension, which means they get dizzy due to a significant drop in blood pressure upon standing. Participants must have this condition confirmed by specific tests showing it's caused by nerve problems.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive various combinations of Droxidopa, Pyridostigmine, and placebo over a 4-day period
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Droxidopa
- Pyridostigmine Bromide
Droxidopa is already approved in United States for the following indications:
- Neurogenic Orthostatic Hypotension (NOH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator