## Protocol Section
### Identification Module
**NCT ID:** NCT00004479

**Brief Title:** Randomized Study of Midodrine, an Alpha Adrenergic Agonist, in Patients With Neurally Mediated Syncope

#### Organization Study ID Info
**ID:** 199/14181
#### Organization
**Class:** NIH
**Full Name:** Office of Rare Diseases (ORD)
#### Secondary ID Infos
**ID:** MTS-GCO-97-160NE
**ID:** ROBERTS-MTS-GCO-97-160NE
### Status Module
#### Expanded Access Info
#### Last Update Post Date
**Date:** 2005-06-24

**Type:** ESTIMATED

**Last Update Submit Date:** 2005-06-23

**Overall Status:** COMPLETED

#### Start Date
**Date:** 1999-03

**Status Verified Date:** 2004-07

#### Study First Post Date
**Date:** 1999-10-19
**Type:** ESTIMATED
**Study First Submit Date:** 1999-10-18
**Study First Submit QC Date:** 1999-10-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Icahn School of Medicine at Mount Sinai

### Description Module

**Brief Summary:** OBJECTIVES:

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

**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.

### Conditions Module

**Conditions:**

- Syncope

**Keywords:**

- neurologic and psychiatric disorders

- rare disease

- syncope

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** midodrine

**Type:** DRUG

### Eligibility Module

**Eligibility 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

**Minimum Age:** 16 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Mount Sinai School of Medicine

**State:** New York

**Zip:** 10029

#### Overall Officials

**Official 1:**

**Affiliation:** Icahn School of Medicine at Mount Sinai

**Name:** Horacio Kaufmann

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014474

- Term: Unconsciousness

- ID: D000003244

- Term: Consciousness Disorders

- ID: D000019954

- Term: Neurobehavioral Manifestations

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M85

- Name: Problem Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M24518

- Name: Rare Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16353

- Name: Syncope

- Relevance: HIGH

- As Found: Syncope

- ID: M21417

- Name: Syncope, Vasovagal

- Relevance: LOW

- As Found: Unknown

- ID: M17224

- Name: Unconsciousness

- Relevance: LOW

- As Found: Unknown

- ID: M6468

- Name: Consciousness Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M21826

- Name: Neurobehavioral Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013575

- Term: Syncope

### Intervention Browse Module - Ancestors

- ID: D000013566

- Term: Sympathomimetics

- ID: D000001337

- Term: Autonomic Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000014662

- Term: Vasoconstrictor Agents

- ID: D000058646

- Term: Adrenergic alpha-1 Receptor Agonists

- ID: D000000316

- Term: Adrenergic alpha-Agonists

- ID: D000000322

- Term: Adrenergic Agonists

- ID: D000018663

- Term: Adrenergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

### Intervention Browse Module - Browse Branches

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11850

- Name: Midodrine

- Relevance: HIGH

- As Found: Treatment program

- ID: M20746

- Name: Adrenergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M3673

- Name: Adrenergic Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M3668

- Name: Adrenergic alpha-Agonists

- Relevance: LOW

- As Found: Unknown

- ID: M16345

- Name: Sympathomimetics

- Relevance: LOW

- As Found: Unknown

- ID: M17409

- Name: Vasoconstrictor Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008879

- Term: Midodrine

### Misc Info Module

- Version Holder: 2024-05-24
