Orthostatic HypotensionPhase 2NCT01370512
Droxidopa / Pyridostigmine in Orthostatic Hypotension
A Phase 2 study testing Droxidopa and Pyridostigmine in people with Orthostatic Hypotension, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Droxidopa and Pyridostigmine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study.
- Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.
Who cannot join
- Pregnant or lactating females.
- 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.
- Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living.
- Any known concurrent infection or severe liver or kidney disease.
- 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with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations.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.
- 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.
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- 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.
- Dementia (DSM-IV criteria - Amer. Psych. Assoc., 1994). The score on the Mini-Mental State Examination must be >24.
- 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).
- History of electroconvulsive therapy.
- History of brain surgery for Parkinson's disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
- Conditions
- Orthostatic Hypotension
- Being tested
- Droxidopa, Pyridostigmine, Placebo
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroxidopaDrug
100 mg tablets by mouth three times a day
PyridostigmineDrug
60 mg tablets by mouth three times a day
PlaceboOther
Looks exactly like the study drug but contains no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Placebo, Then Pyridostigmine | Active comparator | 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. Receives: Drug: Pyridostigmine; Other: Placebo |
| Pyridostigmine, Then Placebo | Active comparator | 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. Receives: Drug: Pyridostigmine; Other: Placebo |
| Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine | Experimental | 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. Receives: Drug: Droxidopa; Drug: Pyridostigmine; Other: Placebo |
| Droxidopa and Pyridostigmine, Then Droxidopa and Placebo | Experimental | 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. Receives: Drug: Droxidopa; Drug: Pyridostigmine; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in orthostatic diastolic blood pressure
diastolic blood pressure measured upon standing reported in mm/Hg
Measured: 1 hour after medication administration, 2 hours after medication administration
Secondary outcomes (5)
Change in orthostatic systolic blood pressure
systolic blood pressure measured upon standing reported in mm/Hg
Measured: 1 hour after medication administration, 2 hours after medication administration
Change in absolute supine diastolic blood pressure
diastolic blood pressure measured while lying flat reported in mm/Hg
Measured: 1 hour after medication administration, 2 hours after medication administration
Change in absolute supine systolic blood pressure
systolic blood pressure measured while lying flat reported in mm/Hg
Measured: 1 hour after medication administration, 2 hours after medication administration
Change in supine norepinephrine levels
measure of serum norepinephrine levels while lying flat reported in pg/mL
Measured: 1 hour after medication administration, 2 hours after medication administration
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
Measured: 1 hour after medication administration, 2 hours after medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled, double-blind, randomized four-way crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Singer, MD, Mayo Clinic
- Investigators
- Wolfgang Singer, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01370512
- Sponsor's protocol ID
- 10-008810
- Other IDs
- P01NS044233
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2011
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
- ClinicalTrials.gov ID
- NCT01370512
- Acronym / sponsor ID
- 10-008810
- Conditions
- Orthostatic Hypotension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Nov 2011
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Placebo-controlled, double-blind, randomized four-way crossover
| Arm | Type | Receives |
|---|---|---|
| Placebo, Then Pyridostigmine | Active comparator | Drug: Pyridostigmine, Other: Placeboparticipants 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. |
| Pyridostigmine, Then Placebo | Active comparator | Drug: Pyridostigmine, Other: Placeboparticipants 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. |
| Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine | Experimental | Drug: Droxidopa, Drug: Pyridostigmine, Other: Placeboparticipants 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. |
| Droxidopa and Pyridostigmine, Then Droxidopa and Placebo | Experimental | Drug: Droxidopa, Drug: Pyridostigmine, Other: Placeboparticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The presence of OH (fall in systolic BP >=30 mm Hg) is required for this study.
- Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.
Key exclusion criteria (11 listed)
- Pregnant or lactating females.
- 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.
- Orthopedic problems or cardiopulmonary disease, sufficient to compromise mobility and activity of daily living.
- Any known concurrent infection or severe liver or kidney disease.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Droxidopa100 mg tablets by mouth three times a day | Drug | Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine, Droxidopa and Pyridostigmine, Then Droxidopa and Placebo |
| Pyridostigmine60 mg tablets by mouth three times a day | Drug | Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine, Droxidopa and Pyridostigmine, Then Droxidopa and Placebo, Placebo, Then Pyridostigmine, Pyridostigmine, Then Placebo |
| PlaceboLooks exactly like the study drug but contains no active ingredients | Other | Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine, Droxidopa and Pyridostigmine, Then Droxidopa and Placebo, Placebo, Then Pyridostigmine, Pyridostigmine, Then Placebo |
Primary outcome
Change in orthostatic diastolic blood pressure
Time frame: 1 hour after medication administration, 2 hours after medication administration
diastolic blood pressure measured upon standing reported in mm/Hg
5 secondary outcomes
Change in orthostatic systolic blood pressure
Time frame: 1 hour after medication administration, 2 hours after medication administration
Change in absolute supine diastolic blood pressure
Time frame: 1 hour after medication administration, 2 hours after medication administration
Change in absolute supine systolic blood pressure
Time frame: 1 hour after medication administration, 2 hours after medication administration
Change in supine norepinephrine levels
Time frame: 1 hour after medication administration, 2 hours after medication administration
Change in orthostatic symptoms
Time frame: 1 hour after medication administration, 2 hours after medication administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wolfgang Singer, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Droxidopa and Pyridostigmine in people with Orthostatic Hypotension, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in orthostatic diastolic blood pressure (time frame: 1 hour after medication administration, 2 hours after medication administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.