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NCT00093860 · ClinicalTrials.gov registry record · Phase 2
Propranolol to Treat Fainting in Children With Sympathoadrenal Imbalance
A Phase 2 study of Syncope, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT00093860 is a Phase 2 study of Syncope that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 50 participants, below the 846-participant average among 11 other Syncope trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00093860, a Phase 2 study of Syncope, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will examine the effectiveness of the drug propranolol in preventing fainting in patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system and chemical responses in which the blood vessels in skeletal muscles do not remain constricted appropriately during standing for a long time. This can lower blood pressure and cause fainting. Propranolol (Inderal® (Registered Trademark)) is a Food and Drug Administration-approved drug that belongs to a class of drugs called beta-blockers. These drugs slow the heart rate and maintain blood pressure in certain situations. Children between 10 and 17 years of age with frequent fainting or near-fainting due to SAI may be eligible for this study. Children must experience severe dizzy episodes at least once every 2 months or fainting episodes at least once every 4 months. The condition must be severe enough to affect the child's quality of life or to have forced the child to alter his or her life routines to accommodate to the illness. Screening includes a tilt table test, described below, to determine if the child has a particular chemical pattern in the blood. Children enrolled in the study take propranolol pills in increasing doses during the first week of the study to determine the proper dose for the individual. Then, the drug is stopped until the experimental phase of the study begins. In this phase, children are randomly assigned to take either propranolol or placebo (a look-alike pill with no active ingredient) for a maximum of 3 days. On the fourth day, the child undergoes a tilt table test to determine whether the treatment affects his or her ability to tolerate tilt. For this test, the child lies on a padded table with a motorized tilt mechanism that can move the child from a flat position to an upright position in about 10 seconds. The child remains upright for up to 40 minutes while the following measurements are taken: * Blood sampling: Blood is drawn through a catheter (th
Conditions Studied
Interventions
- DRUG Propranolol
Study Locations (1)
Maryland
- National Institute of Neurological Disorders and Stroke (NINDS) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2004-10 |
| Est. Completion | 2005-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00093860
The ClinicalTrials.gov registry entry for NCT00093860 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 846-participant average among 11 other Syncope trials with a reported enrollment target (94% lower). The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Syncope appearing as the primary indexed condition, and to 1 intervention - of which Propranolol is the first listed.
NCT00093860 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00093860 about?
NCT00093860 is a clinical study titled "Propranolol to Treat Fainting in Children With Sympathoadrenal Imbalance". This study will examine the effectiveness of the drug propranolol in preventing fainting in patients with sympathoadrenal imbalance (SAI). SAI is a particular pattern of nervous system and chemical responses in which the blood vessels in skeletal muscles do not remain constricted appropriately durin...
What is the current status of trial NCT00093860?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2004-10. Estimated completion is 2005-03.
What conditions does trial NCT00093860 study?
This clinical trial studies the following conditions: Syncope.
What interventions are being tested in trial NCT00093860?
The interventions under investigation include: Propranolol (DRUG).
Who is sponsoring clinical trial NCT00093860?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00093860 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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