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| Sponsor: | St. Luke's-Roosevelt Hospital Center |
|---|---|
| Collaborators: |
National Eye Institute (NEI) University of Rochester University of Iowa University of California, Davis |
| Information provided by (Responsible Party): | Mark Kupersmith, St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT01003639 |
Purpose
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 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Intracranial Hypertension |
Drug: Acetazolamide Drug: Placebo Behavioral: Formal weight loss counselling program |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss |
| Estimated Enrollment: | 154 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Acetazolamide
Acetazolamide given in escalating doses
|
Drug: Acetazolamide
Subjects will begin with four 250 mg tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.
Other Names:
Behavioral: Formal weight loss counselling program
Teleconference, web-based from central location, using site visits and subject self-assessment tools
Other Names:
|
|
Placebo Comparator: Sugar pill
Given in escalating "dose" (number of pill)
|
Drug: Placebo
Subjects will begin with four tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.
Other Names:
Behavioral: Formal weight loss counselling program
Teleconference, web-based from central location, using site visits and subject self-assessment tools
Other Names:
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Iyore Ayanru | (212) 636-3516 | |
| Contact: Ann Stoutenberg, CCRC | (585) 273-2529 | Ann.Stoutenburg@ctcc.rochester.edu |
Show 45 Study Locations| Study Director: | Michael Wall, MD | University of Iowa |
More Information
| Responsible Party: | Mark Kupersmith, MD Chairman of NORDIC, Neuro-Ophthalmology Research Disease Investigator, St. Luke's-Roosevelt Hospital Center |
| ClinicalTrials.gov Identifier: | NCT01003639 History of Changes |
| Other Study ID Numbers: | NORDIC01, 1U10EY017281-01A1, 1U10EY017387-01A1 |
| Study First Received: | October 28, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
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papilledema vision loss headache obesity |
women diplopia tinnitus |
|
Hypertension Pseudotumor Cerebri Intracranial Hypertension Vascular Diseases Cardiovascular Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Acetaminophen Aspirin Naproxen Ibuprofen Acetazolamide Antipyretics Physiological Effects of Drugs |
Pharmacologic Actions Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Anticonvulsants Carbonic Anhydrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Diuretics Natriuretic Agents Cardiovascular Agents Anti-Inflammatory Agents, Non-Steroidal |