Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE2
30 participants
INTERVENTIONAL
2011-11-30
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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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.
Pyridostigmine
60 mg tablets by mouth three times a day
Placebo
Looks exactly like the study drug but contains no active ingredients
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.
Pyridostigmine
60 mg tablets by mouth three times a day
Placebo
Looks exactly like the study drug but contains no active ingredients
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.
Droxidopa
100 mg tablets by mouth three times a day
Pyridostigmine
60 mg tablets by mouth three times a day
Placebo
Looks exactly like the study drug but contains no active ingredients
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.
Droxidopa
100 mg tablets by mouth three times a day
Pyridostigmine
60 mg tablets by mouth three times a day
Placebo
Looks exactly like the study drug but contains no active ingredients
Interventions
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Droxidopa
100 mg tablets by mouth three times a day
Pyridostigmine
60 mg tablets by mouth three times a day
Placebo
Looks exactly like the study drug but contains no active ingredients
Eligibility Criteria
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Inclusion Criteria
2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.
Exclusion Criteria
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 (DSM-IV criteria - Amer. Psych. Assoc., 1994). The score on the Mini-Mental State Examination 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.
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Mayo Clinic
OTHER
Responsible Party
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Wolfgang Singer, MD
Principal Investigator
Principal Investigators
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Wolfgang Singer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Other Identifiers
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10-008810
Identifier Type: -
Identifier Source: org_study_id
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