ClinicalTrials.gg
Enrolling by invitationNCT01370512Updated Jul 15, 2026

Droxidopa / Pyridostigmine in Orthostatic Hypotension

A Phase 2 interventional study of Droxidopa and Pyridostigmine in Orthostatic Hypotension, sponsored by Mayo Clinic. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.

Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 15 studies testing droxidopa in Hypotension, Orthostatic — 2 open to participants now, 2 under way, none of them phase 3. Droxidopa · Hypotension, Orthostatic.

Planned enrollment
7th of 14
30 · median 28
Started
2011
the only one that year
Phase 2
2 of 15
1 open now
Registered
9th of 15
by date
Lead sponsor
1 of 15
Mayo Clinic

Among the 15 studies testing droxidopa in Hypotension, Orthostatic, this one is the 7th largest by planned enrollment of the 14 interventional ones that give a count, is the only one that started in 2011, is one of 2 in phase 2, and was the 9th registered.

Hypotension, Orthostatic

159 studies on the registry are indexed under Hypotension, Orthostatic; 35 are open to participants now.

Browse Hypotension, Orthostatic studies →

Open to participants now

2 of the 15 studies testing droxidopa in Hypotension, Orthostatic are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About droxidopa

Droxidopa: first FDA approval 2014 (NORTHERA). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 23 Hypotension, Orthostatic studies recruiting now, 8 (35%) set no upper age limit and 8 (35%) stop at 75 or younger; 1 takes children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 15 studies testing droxidopa in Hypotension, Orthostatic, or all of them as a file.
02

Study summary

This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.

03

Conditions studied

  • Orthostatic Hypotension
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study.
  2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Chronic illnesses or the presence of other conditions that potentially involve the CNS or affect autonomic testing. These include congestive heart failure, recent (\<6 months) myocardial infarct, severe anemia, diabetes mellitus, alcoholism, malignant neoplasms, amyloidosis, hypothyroidism, sympathectomy, cerebrovascular accidents, and neurotoxins or neuroactive drug exposure.
  3. Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living.
  4. Any known concurrent infection or severe liver or kidney disease.
  5. Medications that could affect autonomic function are suspended prior to autonomic testing. Therapy with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations. Fludrocortisone doses up to 0.2 mg per day will be permitted. Stable doses of antidepressants (tricyclics, SSRIs, SNRIs) will also be permitted. The 48h medication withdrawal is reviewed on a case by case basis - if felt unsafe by the investigators, the withdrawal period may be shortened. This will be documented in the study documents.
  6. Occasional use of a neuroleptic as an anti-emetic in the past is allowed, but none can have been used within 3 weeks prior to this study.
  7. Use of methylphenidate, cinnarizine, reserpine, amphetamine, atypical antipsychotics such as risperidone, olanzapine, and quetiapine or a MAO-A inhibitor within 3 weeks prior to this study.
  8. Dementia ( criteria - Amer. Psych. Assoc., 1994). The score on the must be >24.
  9. History of stroke (diagnosed on clinical grounds as an acute deterioration of neurological function typical of a stroke; confirmatory CT or MRI evidence of stroke will be useful but not necessary).
  10. History of electroconvulsive therapy.
  11. History of brain surgery for Parkinson's disease.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Placebo, Then Pyridostigmine

    participants first receive placebo by mouth 3 times a day, for treatment day 1. Then participants receive pyridostigmine by mouth 3 times a day for treatment day 2.

    Drug: Pyridostigmine · Other: Placebo

  • Active comparator
    Pyridostigmine, Then Placebo

    participants first receive pyridostigmine by mouth 3 times a day, for treatment day 1. Then participants receive placebo by mouth 3 times a day for treatment day 2.

    Drug: Pyridostigmine · Other: Placebo

  • Experimental
    Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine

    participants first receive placebo by mouth 3 times a day, for treatment day 3. Then participants receive Droxidopa by mouth 3 times a day for treatment day 4.

    Drug: Droxidopa · Drug: Pyridostigmine · Other: Placebo

  • Experimental
    Droxidopa and Pyridostigmine, Then Droxidopa and Placebo

    participants first receive Droxidopa by mouth 3 times a day, for treatment day 3. Then participants receive Placebo by mouth 3 times a day for treatment day 4.

    Drug: Droxidopa · Drug: Pyridostigmine · Other: Placebo

Interventions

  • 100 mg tablets by mouth three times a day

  • 60 mg tablets by mouth three times a day

  • OtherPlacebo

    Looks exactly like the study drug but contains no active ingredients

06

What researchers measure

Primary outcomes

  1. Change in orthostatic diastolic blood pressure

    diastolic blood pressure measured upon standing reported in mm/Hg

    Time frame: 1 hour after medication administration, 2 hours after medication administration

Secondary outcomes

  1. Change in orthostatic systolic blood pressure

    systolic blood pressure measured upon standing reported in mm/Hg

    Time frame: 1 hour after medication administration, 2 hours after medication administration

  2. Change in absolute supine diastolic blood pressure

    diastolic blood pressure measured while lying flat reported in mm/Hg

    Time frame: 1 hour after medication administration, 2 hours after medication administration

  3. Change in absolute supine systolic blood pressure

    systolic blood pressure measured while lying flat reported in mm/Hg

    Time frame: 1 hour after medication administration, 2 hours after medication administration

  4. Change in supine norepinephrine levels

    measure of serum norepinephrine levels while lying flat reported in pg/mL

    Time frame: 1 hour after medication administration, 2 hours after medication administration

  5. Change in orthostatic symptoms

    measured during tilt study, the patient will be asked to score orthostatic symptoms on a symptom scale ranging from "0" = no symptoms to "10" = near syncope

    Time frame: 1 hour after medication administration, 2 hours after medication administration

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2011, a primary completion of May 2027 and a completion of May 2027. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 8, 2011
First posted
Jun 10, 2011
Start
Nov 2011
Primary completionEst.
May 2027
CompletionEst.
May 2027
Last update
Jul 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01370512
Lead sponsor
Mayo Clinic
Responsible party
Wolfgang Singer, MD (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Jun 10, 2011
Start date
Nov 2011
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Jul 15, 2026

Study contacts

Wolfgang Singer, M.D.
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drug tested here: Droxidopa

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