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Trial record 1 of 1 for:    NCT01370512
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Droxidopa / Pyridostigmine in Orthostatic Hypotension

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ClinicalTrials.gov Identifier: NCT01370512
Recruitment Status : Completed
First Posted : June 10, 2011
Last Update Posted : June 23, 2022
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Phillip Low, Mayo Clinic

Brief Summary:
The hypothesis is that pyridostigmine will improve the safety factor of ganglionic neural transmission, while Droxidopa will replete the postganglionic neuron of norepinephrine (NE). This combination should result in enhanced orthostatic release of NE. The investigators have already demonstrated that pyridostigmine does not raise supine blood pressure.

Condition or disease Intervention/treatment Phase
Orthostatic Hypotension Drug: Droxidopa Drug: Pyridostigmine Other: Placebo Other: Placebo 2 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Placebo-controlled, double-blind, randomized four-way crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
Study Start Date : November 2011
Actual Primary Completion Date : January 19, 2021
Actual Study Completion Date : January 19, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: droxidopa plus pyridostigmine
droxidopa 100mg by mouth three times a day plus pyridostigmine 60mg by mouth three times a day (one day)
Drug: Droxidopa
Droxidopa 100 mg three times a day

Drug: Pyridostigmine
Pyridostigmine 60 mg three times a day

Active Comparator: droxidopa
droxidopa 100mg by mouth three times a day plus placebo (for pyridostigmine) by mouth three times a day (one day)
Drug: Droxidopa
Droxidopa 100 mg three times a day

Other: Placebo 2
Placebo for pyridostigmine

Active Comparator: pyridostigmine
pyridostigmine 60mg by mouth three times a day plus placebo (for droxidopa) by mouth three times a day
Drug: Pyridostigmine
Pyridostigmine 60 mg three times a day

Other: Placebo
Placebo for droxidopa

Placebo Comparator: placebo
placebo (for pyridostigmine) by mouth three times a day plus placebo (for droxidopa) by mouth three times a day
Other: Placebo
Placebo for droxidopa

Other: Placebo 2
Placebo for pyridostigmine




Primary Outcome Measures :
  1. Effect of treatment on the orthostatic decline in blood pressure [ Time Frame: 1h and 2h after medication ]
    Effect of treatment on the orthostatic decline in blood pressure at 1h and 2h after medication


Secondary Outcome Measures :
  1. Effect of treatment on the absolute standing BP [ Time Frame: 1h and 2h after medication ]
    Effect of treatment on the absolute standing BP at 1h and 2h after medication

  2. Effect of treatment on the absolute supine BP [ Time Frame: 1h and 2h after medication ]
    Effect of treatment on the absolute supine BP at 1h and 2h after medication

  3. Effect of treatment on norepinephrine [ Time Frame: 1h and 2h after medication ]
    Effect of treatment on norepinephrine at 1h and 2h after medication

  4. Effect of treatment on orthostatic symptoms [ Time Frame: 1h and 2h after medication ]
    Effect of treatment on orthostatic symptoms at 1h and 2h after medication



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  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 (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370512


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Phillip A Low, M.D. Mayo Clinic
Additional Information:
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Responsible Party: Phillip Low, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01370512    
Other Study ID Numbers: 10-008810
P01NS044233 ( U.S. NIH Grant/Contract )
First Posted: June 10, 2011    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypotension, Orthostatic
Hypotension
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Droxidopa
Pyridostigmine Bromide
Antiparkinson Agents
Anti-Dyskinesia Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs