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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: Clinical Trial Phase 3 study, sponsored by Jaeb Center for Health Research.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline to first of Month 6 (Week 26) or time of treatment failure in PMD (perimetric mean deviation) in eligible eye(s) with the size V stimulus
Interventions
- DRUG Acetazolamide
- PROCEDURE Optic Nerve Sheath Fenestration
- PROCEDURE Ventriculoperitoneal CSF Shunting
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2019-02-06 |
| Est. Completion | 2019-08-28 |
| Phase | Phase 3 |
Why NCT03501966 stopped before completion
NCT03501966 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Acetazolamide is the first listed.
NCT03501966 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03501966's enrollment target sits among peer trials
7 1995th of 2000 higher than 6 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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