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Droxidopa / Pyridostigmine in Orthostatic Hypotension

This study is currently recruiting participants.
Verified January 2013 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 9, 2013
Last verified: January 2013
History of Changes
  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
Multiple System Atrophy
 Drug: Droxidopa
Drug: Pyridostigmine Bromide
 Phase 3

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:

U.S. FDA Resources

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: 6 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: 6 days ] [ Designated as safety issue: Yes ]
  • Evaluate the effect of Droxidopa alone versus Droxidopa combined with pyridostigmine on orthostatic symptoms. [ Time Frame: 6 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:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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    
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Phillip Low, MD 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 9, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Hypotension, Orthostatic
Multiple System Atrophy
Shy-Drager Syndrome
Atrophy
Vascular Diseases
Cardiovascular Diseases
Orthostatic Intolerance
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
 Neurodegenerative Diseases
Pathological Conditions, Anatomical
Droxidopa
Bromides
Pyridostigmine Bromide
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anticonvulsants
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents

ClinicalTrials.gov processed this record on May 16, 2013