Droxidopa / Pyridostigmine in Orthostatic Hypotension
Phase 2
- Conditions
- Orthostatic Hypotension
- Interventions
- Registration Number
- NCT01370512
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This study is being done to study the combination of pyridostigmine and low-dose Droxidopa for the treatment of orthostatic hypotension.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
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with midodrine, alpha and beta adrenergic antagonists, or other medications that affect autonomic function will be withdrawn 48 hours prior to autonomic evaluations.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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo, Then Pyridostigmine 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. Placebo, Then Pyridostigmine Placebo 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. Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine Placebo 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. Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine Droxidopa 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 and Pyridostigmine, Then Droxidopa and Placebo Droxidopa 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 and Pyridostigmine, Then Droxidopa and Placebo Pyridostigmine 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. Pyridostigmine, Then Placebo Pyridostigmine 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, Then Placebo 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. Droxidopa and Pyridostigmine, Then Droxidopa and Placebo 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. Drioxidopa and Placebo, Then Drioxidopa and Pyridostigmine 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.
- Primary Outcome Measures
Name Time Method Change in orthostatic diastolic blood pressure 1 hour after medication administration, 2 hours after medication administration diastolic blood pressure measured upon standing reported in mm/Hg
- Secondary Outcome Measures
Name Time Method Change in absolute supine diastolic blood pressure 1 hour after medication administration, 2 hours after medication administration diastolic blood pressure measured while lying flat reported in mm/Hg
Change in supine norepinephrine levels 1 hour after medication administration, 2 hours after medication administration measure of serum norepinephrine levels while lying flat reported in pg/mL
Change in orthostatic symptoms 1 hour after medication administration, 2 hours after medication administration 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
Change in orthostatic systolic blood pressure 1 hour after medication administration, 2 hours after medication administration systolic blood pressure measured upon standing reported in mm/Hg
Change in absolute supine systolic blood pressure 1 hour after medication administration, 2 hours after medication administration systolic blood pressure measured while lying flat reported in mm/Hg
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States