Trial · NCT01003639
Idiopathic Intracranial Hypertension Treatment Trial
NCT01003639, Phase 2, Phase 3, Completed, St. Luke's-Roosevelt Hospital Center; results first posted 2018-12-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Idiopathic Intracranial Hypertension Treatment Trial. Trials, record NCT01003639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01003639
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Idiopathic Intracranial Hypertension Treatment Trial
- NCT number
- NCT01003639
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 165 participants, actual
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Conditions
- Idiopathic Intracranial Hypertension
- Interventions
- Acetazolamide, Placebo, Formal weight loss counselling program
- First posted
- 2009-10-29
- Last updated
- 2018-12-12
- Results first posted
- 2018-12-12
- Limitations and caveats
A limitation is the 19% withdrawal rate which may be due, in part, to the intensity of the visit schedule. Another limitation is the difficulty in the interpretation of the estimated treatment effect on PMD.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Perimetric Mean Deviation | base line and 6 months | 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. |
| Secondary | Mean Change of Papilledema Grade on Fundus Photography | Baseline and 6 Months | Mean change at month 6 as compared to baseline. Frisén papilledema grade is an ordinal scale that uses ocular fundus features to rate the severity of papilledema; grade 0 indicates no features of papilledema and grade 5 indicates severe papilledema. |
| Secondary | Visual Function Questionnaire (VFQ-25) | baseline | Visual Function Questionnaire (VFQ-25) total score, VFQ-25 10-item neuro-ophthalmic supplement total score: 0-100 (higher scores indicate better quality of life) |
| Secondary | Visual Acuity (No. of Correct Letters) | Baseline |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Perimetric Mean Deviation | base line and 6 months | Sixty-nine of the 86 participants (80%) in the acetazolamide group completed follow-up compared with 57 of the 79 participants (72%) in the placebo group. | dB | MEAN |
| SECONDARY | Mean Change of Papilledema Grade on Fundus Photography | Baseline and 6 Months | Sixty-nine of the 86 participants (80%) in the acetazolamide group completed follow-up compared with 57 of the 79 participants (72%) in the placebo group. | units on a scale | MEAN |
| SECONDARY | Visual Function Questionnaire (VFQ-25) | baseline | units on a scale | MEAN | |
| SECONDARY | Visual Acuity (No. of Correct Letters) | Baseline | correct letters | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Perimetric Mean Deviation | Acetazolamide | 1.43 | Standard Error 0.24 | dB | |
| Mean Change in Perimetric Mean Deviation | Sugar Pill | 0.71 | Standard Error 0.28 | dB | |
| Mean Change of Papilledema Grade on Fundus Photography | Acetazolamide | Study eye | -1.31 | Standard Error 0.11 | units on a scale |
| Mean Change of Papilledema Grade on Fundus Photography | Sugar Pill | Study eye | -0.61 | Standard Error 0.11 | units on a scale |
| Mean Change of Papilledema Grade on Fundus Photography | Acetazolamide | Fellow eye | -1.14 | Standard Error 0.10 | units on a scale |
| Mean Change of Papilledema Grade on Fundus Photography | Sugar Pill | Fellow eye | -0.52 | Standard Error 0.11 | units on a scale |
| Visual Function Questionnaire (VFQ-25) | Acetazolamide | Total score | 83.8 | Standard Deviation 14.1 | units on a scale |
| Visual Function Questionnaire (VFQ-25) | Sugar Pill | Total score | 82.1 | Standard Deviation 13.4 | units on a scale |
| Visual Function Questionnaire (VFQ-25) | Acetazolamide | 10-item neuro-ophthalmic supplement | 75.8 | Standard Deviation 15.4 | units on a scale |
| Visual Function Questionnaire (VFQ-25) | Sugar Pill | 10-item neuro-ophthalmic supplement | 75.0 | Standard Deviation 13.7 | units on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acetazolamide | 86 | |
| Overall Study | STARTED | Sugar Pill | 79 | |
| Overall Study | COMPLETED | Acetazolamide | 69 | |
| Overall Study | COMPLETED | Sugar Pill | 57 | |
| Overall Study | NOT COMPLETED | Acetazolamide | 17 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 22 |
Source ClinicalTrials.gov
Adverse events74
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Elevated ALT | Hepatobiliary disorders | Acetazolamide | 6 | 86 | 6 |
| other | Elevated ALT | Hepatobiliary disorders | Sugar Pill | 3 | 79 | 4 |
| other | Decreased CO2 | General disorders | Acetazolamide | 9 | 86 | 9 |
| other | Decreased CO2 | General disorders | Sugar Pill | 0 | 79 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Acetazolamide | 12 | 86 | 14 |
| other | Diarrhea | Gastrointestinal disorders | Sugar Pill | 3 | 79 | 4 |
| other | Dizziness | General disorders | Acetazolamide | 8 | 86 | 11 |
| other | Dizziness | General disorders | Sugar Pill | 3 | 79 | 4 |
| other | Dysgeusia | General disorders | Acetazolamide | 13 | 86 | 13 |
| other | Dysgeusia | General disorders | Sugar Pill | 0 | 79 | 0 |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acetazolamide | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Acetazolamide | 80 | 86 |
| Total, other adverse events | Sugar Pill | 67 | 79 |
| Total, serious adverse events | Acetazolamide | 9 | 86 |
| Total, serious adverse events | Sugar Pill | 7 | 79 |
Source ClinicalTrials.gov
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| U10EY017281 | Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) Network | KUPERSMITH, MARK J | ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS | NATIONAL EYE INSTITUTE | 2009 to 2014 | NIH RePORTER |
| U10EY017387 | Data Coordination and Biostatistics Center for the NORDIC Network | KIEBURTZ, KARL D. | UNIVERSITY OF ROCHESTER | NATIONAL EYE INSTITUTE | 2009 to 2013 | NIH RePORTER |
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Acetazolamide vs Sugar Pill: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01003639
GET https://conductscience.org/api/trials/v1/NCT01003639/events?page=2