Droxidopa / Pyridostigmine in Orthostatic Hypotension

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Phillip Low, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01370512
First received: June 8, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Orthostatic Hypotension
Drug: Droxidopa
Drug: Pyridostigmine Bromide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment Trial of Droxidopa and Pyridostigmine to Improve Orthostatic Hypotension Without Aggravating Supine Hypertension

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • The primary endpoint is the improvement in diastolic BP fall at the end of 5 minutes of standing. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine versus placebo on supine NE and its orthostatic increment. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
  • Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms. [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Droxidopa / Pyridostigmine Drug: Droxidopa
100 mg t.i.d. for 2 days; then 200 mg t.i.d. for another 2 days
Drug: Pyridostigmine Bromide
180 mg daily for 4 days
Placebo Comparator: Droxidopa Drug: Droxidopa
100 mg t.i.d. for 2 days; then 200 mg t.i.d. for another 2 days
Placebo Comparator: Pyridostigmine Drug: Pyridostigmine Bromide
180 mg daily for 4 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. The presence of orthostatic hypotension (fall in systolic BP greater than or equal to 30 mm Hg) is required for this study;
  2. Autonomic testing and clinical evaluation demonstrates OH to be of neurogenic etiology.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01370512

Contacts
Contact: Tonette Gehrking 507-284-0336 adc.research@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tonette Gehrking    507-284-0336    adc.research@mayo.edu   
Principal Investigator: Phillip A. Low, MD         
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

Responsible Party: Phillip Low, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01370512     History of Changes
Other Study ID Numbers: 10-008810
Study First Received: June 8, 2011
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Autonomic Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Vascular Diseases
Droxidopa
Pyridostigmine Bromide
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014