Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope

This study has been completed.

Sponsored by:	Mount Sinai School of Medicine
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004479

Purpose

OBJECTIVES:

Determine the efficacy of midodrine, a selective alpha 1 adrenergic agonist, in preventing neurally mediated syncope.

Condition	Intervention
Syncope	Drug: midodrine

MedlinePlus related topics: Fainting

Drug Information available for: Midodrine Midodrine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date:

March 1999

Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind, crossover, placebo-controlled study.

On day one, patients receive either midodrine or placebo. On day three, patients receive the opposite drug.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Diagnosis of neurally mediated syncope (vasovagal fainting) Sudden fall in blood pressure AND Slowing of the heart AND Temporary loss of consciousness AND Hemodynamic response to head up tilt --Prior/Concurrent Therapy-- No other concurrent adrenergic agonist or antiagonist --Patient Characteristics-- Fertile patients must use effective birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004479

Locations

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029

Sponsors and Collaborators

Mount Sinai School of Medicine

Investigators

Study Chair:

Horacio Kaufmann

Mount Sinai School of Medicine

More Information

Study ID Numbers:	199/14181, MTS-GCO-97-160NE, ROBERTS-MTS-GCO-97-160NE
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004479
Health Authority:	Unspecified

Keywords provided by Office of Rare Diseases (ORD):

neurologic and psychiatric disorders
rare disease
syncope

Study placed in the following topic categories:

Signs and Symptoms
Unconsciousness
Mental Disorders
Consciousness Disorders
Midodrine

Rare Diseases
Neurologic Manifestations
Neurobehavioral Manifestations
Syncope

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Nervous System Diseases
Physiological Effects of Drugs

Cardiovascular Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009