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NCT04977388 · ClinicalTrials.gov registry record · Phase 1

NORTHERA (DROXIDOPA) for Dysautonomia in Adult Survivors of Menkes Disease and Occipital Horn Syndrome

A Phase 1 study of Menkes Disease and Occipital Horn Syndrome, sponsored by Stephen G. Kaler, MD.

Completed
Registry status
Phase 1
Development phase
3
Enrollment target
1
Study location

NCT04977388 is a Phase 1 study of Menkes Disease and Occipital Horn Syndrome that has completed, run by Stephen G. Kaler, MD. The registered enrollment target is 3 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT04977388, a Phase 1 study of Menkes Disease and Occipital Horn Syndrome, has completed, sponsored by Stephen G. Kaler, MD.

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to evaluate whether Northera (Droxidopa) is safe and effective in young adults with Menkes disease who survived the most severe complications of their illness or adults with occipital horn syndrome (OHS), who have trouble with intermittent low blood pressure and other symptoms of dysautonomia. The outcomes and information from this study may help adult survivors of Menkes disease and individuals with OHS lead more normal day-to-day lives.

Interventions

  • OTHER Placebo
  • DRUG Droxidopa

Study Locations (1)

New York

  • Vagelos College of Physicians and Surgeons, Columbia University - New York

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2021-07-12
Est. Completion 2024-06-29
Phase Phase 1

Sponsor

Stephen G. Kaler, MD

1 total trials

What the Registry Record Tells You About NCT04977388

The ClinicalTrials.gov registry entry for NCT04977388 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stephen G. Kaler, MD, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Menkes Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04977388 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT04977388 about?

NCT04977388 is a clinical study titled "NORTHERA (DROXIDOPA) for Dysautonomia in Adult Survivors of Menkes Disease and Occipital Horn Syndrome". The purpose of this study is to evaluate whether Northera (Droxidopa) is safe and effective in young adults with Menkes disease who survived the most severe complications of their illness or adults with occipital horn syndrome (OHS), who have trouble with intermittent low blood pressure and other sy...

What is the current status of trial NCT04977388?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2021-07-12. Estimated completion is 2024-06-29.

What conditions does trial NCT04977388 study?

This clinical trial studies the following conditions: Menkes Disease, Occipital Horn Syndrome.

What interventions are being tested in trial NCT04977388?

The interventions under investigation include: Placebo (OTHER), Droxidopa (DRUG).

Who is sponsoring clinical trial NCT04977388?

This trial is sponsored by Stephen G. Kaler, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04977388 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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