Enrolling by invitation NCT01370512
Droxidopa / Pyridostigmine in Orthostatic Hypotension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Droxidopa, Pyridostigmine, Placebo.
- Who it may be relevant to
- Registry conditions: Orthostatic Hypotension. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
Overview
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
Interventions
- Drug Droxidopa
100 mg tablets by mouth three times a day - Drug Pyridostigmine
60 mg tablets by mouth three times a day - Other Placebo
Looks exactly like the study drug but contains no active ingredients
Primary outcome measures
- Change in orthostatic diastolic blood pressure [Time frame: 1 hour after medication administration, 2 hours after medication administration]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT01370512 · 10-008810 · P01NS044233