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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 is a Phase 2 study that has completed, run by St. Luke's-Roosevelt Hospital Center. The registered enrollment target is 165 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01003639
The ClinicalTrials.gov registry entry for NCT01003639 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Luke's-Roosevelt Hospital Center, which has 57 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01003639 reports 0 study locations.
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.
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