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NCT03501966 · ClinicalTrials.gov registry record · Phase 3

Surgical Idiopathic Intracranial Hypertension Treatment Trial

A Phase 3 study, sponsored by Jaeb Center for Health Research.

Terminated
Registry status
Phase 3
Development phase
7
Enrollment target

NCT03501966 is a Phase 3 study that was terminated before completion, run by Jaeb Center for Health Research. The registered enrollment target is 7 participants.

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The verdict

NCT03501966, a Phase 3 study, was terminated before completion, sponsored by Jaeb Center for Health Research.

TERMINATED
Registry status
Phase 3
Development phase
7 participants
Enrollment target

Study Summary

Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure. The determination of eligible eye(s) is based on meeting the eligibility criteria at baseline.

Interventions

  • DRUG Acetazolamide
  • PROCEDURE Optic Nerve Sheath Fenestration
  • PROCEDURE Ventriculoperitoneal CSF Shunting

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2019-02-06
Est. Completion 2019-08-28
Phase Phase 3

Sponsor

Jaeb Center for Health Research

119 total trials

What the Registry Record Tells You About NCT03501966

The ClinicalTrials.gov registry entry for NCT03501966 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jaeb Center for Health Research, which has 119 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Acetazolamide is the first listed.

NCT03501966 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03501966 about?

NCT03501966 is a clinical study titled "Surgical Idiopathic Intracranial Hypertension Treatment Trial". Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual...

What is the current status of trial NCT03501966?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 7 participants. The study started on 2019-02-06. Estimated completion is 2019-08-28.

What interventions are being tested in trial NCT03501966?

The interventions under investigation include: Acetazolamide (DRUG), Optic Nerve Sheath Fenestration (PROCEDURE), Ventriculoperitoneal CSF Shunting (PROCEDURE).

Who is sponsoring clinical trial NCT03501966?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.