Treatment of Orthostatic Intolerance

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

April 30, 1997

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
TachycardiaChronic Orthostatic Intolerance
Interventions
DRUG

Acetazolamide

250 mg PO x 1

DRUG

Atomoxetine

10-40 mg PO x 1 dose

OTHER

NO Drug

No intervention - just monitoring

DRUG

Clonidine

Clonidine 0.05-0.3 mg PO x 1 dose

DRUG

Entacapone

Entacapone 200-400 mg PO x 1 dose

DRUG

Entacapone & Propranolol

Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose

DRUG

Atomoxetine & Propranolol

Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose

DRUG

Indomethacin

Indomethacin 25-50 mg PO x 1 dose

DRUG

Mecamylamine

mecamylamine 1.25-5 mg PO x 1 dose

DRUG

Isosorbide Dinitrate

Isosorbide dinitrate 5-20 mg PO x 1 dose

DIETARY_SUPPLEMENT

Melatonin

melatonin 3 mg PO x 1 dose

DRUG

Midodrine

midodrine 2.5-10 mg PO x 1 dose

DRUG

Modafinil

modafinil 100-200 mg PO x 1 dose

DRUG

Octreotide

octreotide 12.5-50 mcg Subcutaneous x 1 dose

RADIATION

Placebo

lactose tablet x 1 pill

DRUG

Propranolol

Propranolol 10-80 mg PO x 1-2 dose

DRUG

Modafinil & Propranolol

Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose

DRUG

Sertraline

sertraline 25-50 mg PO x 1 dose

PROCEDURE

IV Saline

1 liter IV over 2 hours

OTHER

Drinking Water

16 fluid ounces

DEVICE

Breathing Device

Breathing through a dead space tube

DRUG

memantine

memantine 5-20 mg PO x 1 dose

DEVICE

Abdominal binder

Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.

Trial Locations (1)

37232-2195

Vanderbilt University Autonomic Dysfunction Center, Nashville

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

lead

Satish R. Raj

OTHER

NCT00262470 - Treatment of Orthostatic Intolerance | Biotech Hunter | Biotech Hunter