Droxidopa / Pyridostigmine in Orthostatic Hypotension
Information source: Mayo Clinic
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Orthostatic Hypotension; Multiple System Atrophy
Intervention: Droxidopa (Drug); Pyridostigmine Bromide (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Mayo Clinic Official(s) and/or principal investigator(s):
Phillip Low, MD, Principal Investigator, Affiliation: Mayo Clinic
Overall contact:
Tonette Gehrking, Phone: 507-284-0336, Email: adc.research@mayo.edu
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.
Clinical Details
Official title: Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing.
Secondary outcome: Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine versus placebo on supine NE and its orthostatic increment.Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
The diagnosis of probable MSA requires:
1. the presence of orthostatic hypotension (fall in systolic BP greater than or equal to
30 mm Hg) or urinary incontinence (persistent involuntary partial or total bladder
emptying, accompanied by erectile dysfunction [in men]) or both;
2. poorly levodopa responsive parkinsonism or cerebellar ataxia.
Locations and Contacts
Tonette Gehrking, Phone: 507-284-0336, Email: adc.research@mayo.edu
Mayo Clinic in Rochester, Rochester, Minnesota 55905, United States; Recruiting
Tonette Gehrking, Phone: 507-284-0336, Email: adc.research@mayo.edu
Additional Information
Starting date: November 2011
Last updated: January 9, 2013
|
