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NCT01003639 · ClinicalTrials.gov registry record · Phase 2
Idiopathic Intracranial Hypertension Treatment Trial
A Phase 2 study, sponsored by St. Luke's-Roosevelt Hospital Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
NCT01003639: Completed Phase 2 study, sponsored by St. Luke's-Roosevelt Hospital Center.
NCT01003639 is a Phase 2 study that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 165 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01003639, a Phase 2 study, has completed, sponsored by St. Luke's-Roosevelt Hospital Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
Study Summary
Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause \[Corbett, et al., 1982; Wall, et al., 1991\]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising \[Garrett, et al., 2004\] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss \[Wall, et al., 1991\]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
Primary Outcome
Treatment Effects on the Primary Outcome Variable, Mean change From Baseline to Month 6 in Perimetric Mean Deviation (PMD) in the Study Eye. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss.
Interventions
- DRUG Placebo
- DRUG Acetazolamide
- BEHAVIORAL Formal weight loss counselling program
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT01003639 record still lists
NCT01003639 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01003639 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01003639 about?
NCT01003639 is a clinical study titled "Idiopathic Intracranial Hypertension Treatment Trial". Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause \[Corbett, et al., 1982; Wall, et al., 1991\]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising \[Gar...
What is the current status of trial NCT01003639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2010-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01003639?
The interventions under investigation include: Placebo (DRUG), Acetazolamide (DRUG), Formal weight loss counselling program (BEHAVIORAL).
Who is sponsoring clinical trial NCT01003639?
This trial is sponsored by St. Luke's-Roosevelt Hospital Center, which has 57 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01003639's enrollment target sits among peer trials
165 410th of 2000 higher than 1,588 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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