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Trial record 5 of 37 for:    idiopathic intracranial hypertension

Idiopathic Intracranial Hypertension Treatment Trial (IIHTT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01003639
Recruitment Status : Completed
First Posted : October 29, 2009
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
University of Rochester
University of Iowa
University of California, Davis
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Idiopathic Intracranial Hypertension
Interventions Drug: Acetazolamide
Drug: Placebo
Behavioral: Formal weight loss counselling program
Enrollment 165
Recruitment Details Participants were enrolled at 38 academic and private practice sites in North America from March 2010 to November 2012,with follow-up ending in June 2013.
Pre-assignment Details Randomization was stratified by site and included blocking to ensure balance among the treatment groups within a site after every 4 participants had been enrolled at that site.
Arm/Group Title Acetazolamide Sugar Pill
Hide Arm/Group Description

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

Period Title: Overall Study
Started 86 79
Completed 69 57
Not Completed 17 22
Reason Not Completed
Lost to Follow-up             6             9
Withdrawal by Subject             9             5
Lack of Efficacy             1             6
Adverse Event             0             1
Protocol Violation             0             1
Physician Decision             1             0
Arm/Group Title Acetazolamide Sugar Pill Total
Hide Arm/Group Description

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

Total of all reporting groups
Overall Number of Baseline Participants 86 79 165
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 86 participants 79 participants 165 participants
28.2  (6.9) 30.0  (8.0) 29.0  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Female
84
  97.7%
77
  97.5%
161
  97.6%
Male
2
   2.3%
2
   2.5%
4
   2.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
25
  29.1%
16
  20.3%
41
  24.8%
White
54
  62.8%
54
  68.4%
108
  65.5%
More than one race
4
   4.7%
2
   2.5%
6
   3.6%
Unknown or Not Reported
3
   3.5%
7
   8.9%
10
   6.1%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 86 participants 79 participants 165 participants
108.1  (25.6) 107.3  (24.5) 107.7  (25.0)
Body mass index   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 86 participants 79 participants 165 participants
40.0  (8.5) 39.9  (8.1) 39.9  (8.3)
[1]
Measure Description: Body mass index is calculated as weight in kilograms divided by height in meters squared.
Weight change in the past 6 mo  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 86 participants 79 participants 165 participants
10.7  (16.7) 8.8  (16.9) 9.8  (16.7)
Transient visual obscurations  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
yes 55 57 112
No 31 22 53
Diplopia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Yes 20 16 36
No 66 63 129
Constant visual loss  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Yes 25 28 53
No 61 51 112
Photophobia  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Yes 42 37 79
No 44 42 86
Headache  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Yes 70 69 139
No 16 10 26
Pulsatile tinnitus  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Yes 45 41 86
No 41 38 79
Perimetric mean deviation   [1] 
Mean (Standard Deviation)
Unit of measure:  dB
Number Analyzed 86 participants 79 participants 165 participants
Study eye -3.5  (1.2) -3.5  (1.1) -3.5  (1.1)
Fellow eye -2.3  (1.1) -2.3  (1.1) -2.3  (1.1)
[1]
Measure Description: 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.
Papilledema grade (fundus photography) Study Eye   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Study eye 1 8 12 20
Study eye 2 32 23 55
Study eye 3 20 20 40
Study eye 4 24 21 45
Study eye 5 2 3 5
[1]
Measure Description: 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.
Papilledema grade (fundus photography) Fellow eye   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 86 participants 79 participants 165 participants
Fellow eye 1 15 14 29
Fellow eye 2 33 28 61
Fellow eye 3 19 21 40
Fellow eye 4 19 14 33
Fellow eye 5 0 2 2
[1]
Measure Description: 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.
HIT-6 total score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 86 participants 79 participants 165 participants
60.3  (8.7) 59.1  (9.3) 59.7  (9.0)
[1]
Measure Description:

6-Item Headache Impact Test.

HIT-6 total score: 36-78 (higher scores indicate greater headache severity)

CSF pressure   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm H2O
Number Analyzed 86 participants 79 participants 165 participants
348.9  (94.1) 342.0  (70.7) 343.5  (86.9)
[1]
Measure Description: cerebrospinal fluid
SF-36 component summary score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 86 participants 79 participants 165 participants
Physical 45.4  (9.8) 46.3  (8.2) 45.8  (9.0)
Mental 45.2  (9.8) 46.3  (8.2) 45.8  (9.0)
[1]
Measure Description: Generic health-related quality of life was assessed with the 36-Item Short Form Health Survey - SF-36 consists of eight scaled scores (vitality, physical functioning bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health) : with weighted sums 0-100 (higher scores indicate better quality of life)
1.Primary Outcome
Title Mean Change in Perimetric Mean Deviation
Hide Description 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.
Time Frame base line and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Acetazolamide Sugar Pill
Hide Arm/Group Description:

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

Overall Number of Participants Analyzed 69 57
Mean (Standard Error)
Unit of Measure: dB
1.43  (0.24) 0.71  (0.28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Acetazolamide, Sugar Pill
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.71
Confidence Interval (2-Sided) 95%
0 to 1.43
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change of Papilledema Grade on Fundus Photography
Hide Description 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.
Time Frame Baseline and 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Acetazolamide Sugar Pill
Hide Arm/Group Description:

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

Overall Number of Participants Analyzed 69 57
Mean (Standard Error)
Unit of Measure: units on a scale
Study eye -1.31  (0.11) -0.61  (0.11)
Fellow eye -1.14  (0.10) -0.52  (0.11)
3.Secondary Outcome
Title Visual Function Questionnaire (VFQ-25)
Hide Description 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)
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetazolamide Sugar Pill
Hide Arm/Group Description:

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

Overall Number of Participants Analyzed 86 79
Mean (Standard Deviation)
Unit of Measure: units on a scale
Total score 83.8  (14.1) 82.1  (13.4)
10-item neuro-ophthalmic supplement 75.8  (15.4) 75.0  (13.7)
4.Secondary Outcome
Title Visual Acuity (No. of Correct Letters)
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetazolamide Sugar Pill
Hide Arm/Group Description:

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

Overall Number of Participants Analyzed 86 79
Mean (Standard Deviation)
Unit of Measure: correct letters
Study Eye 56.8  (5.1) 55.6  (5.9)
Fellow Eye 58.3  (4.3) 56.2  (6.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetazolamide Sugar Pill
Hide Arm/Group Description

Acetazolamide given in escalating doses

Acetazolamide: Subjects will begin with four 250 mg tablets daily.

Given in escalating "dose" (number of pill)

Placebo: Subjects will begin with four tablets daily.

All-Cause Mortality
Acetazolamide Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acetazolamide Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/86 (10.47%)      7/79 (8.86%)    
Ear and labyrinth disorders     
Diplopia  0/86 (0.00%)  1/79 (1.27%)  1
Eye disorders     
Rapidly failing vision [1]  0/86 (0.00%)  2/79 (2.53%)  2
Gastrointestinal disorders     
Diverticulitis  1/86 (1.16%)  1 0/79 (0.00%) 
Immune system disorders     
Allergic reaction of unknown origin  1/86 (1.16%)  1 0/79 (0.00%) 
Infections and infestations     
Pyelonephritis  1/86 (1.16%)  1 0/79 (0.00%) 
Bronchitis  0/86 (0.00%)  1/79 (1.27%)  1
Injury, poisoning and procedural complications     
Ventriculoperitoneal shunt malfunction  0/86 (0.00%)  1/79 (1.27%)  1
Investigations     
Transaminitis  1/86 (1.16%)  1 0/79 (0.00%) 
Elevated lipase with pancreatititis  1/86 (1.16%)  1 0/79 (0.00%) 
Metabolism and nutrition disorders     
Hypokalemia  1/86 (1.16%)  1 0/79 (0.00%) 
Nervous system disorders     
Intracranial pressure increased  0/86 (0.00%)  1/79 (1.27%)  1
Pregnancy, puerperium and perinatal conditions     
Live Birth  2/86 (2.33%)  2 0/79 (0.00%) 
Psychiatric disorders     
Suicidal ideation  0/86 (0.00%)  1/79 (1.27%)  1
Renal and urinary disorders     
Renal impairment  1/86 (1.16%)  1 0/79 (0.00%) 
Hydronephrosis  1/86 (1.16%)  1 0/79 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia  0/86 (0.00%)  1/79 (1.27%)  1
Pulmnary embolism  0/86 (0.00%)  1/79 (1.27%)  1
Surgical and medical procedures     
Caesarean section  1/86 (1.16%)  1 0/79 (0.00%) 
Ventriculo-peritoneal shunt  0/86 (0.00%)  1/79 (1.27%)  1
Vascular disorders     
Deep vein thrombosis  0/86 (0.00%)  1/79 (1.27%)  1
[1]
Rapidly failing vision requiring hospitalization and treatment with optic nerve sheath fenestration
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acetazolamide Sugar Pill
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/86 (93.02%)      67/79 (84.81%)    
Ear and labyrinth disorders     
Tinnitus  11/86 (12.79%)  12 3/79 (3.80%)  3
Gastrointestinal disorders     
Diarrhea  12/86 (13.95%)  14 3/79 (3.80%)  4
Dyspepsia  7/86 (8.14%)  8 1/79 (1.27%)  1
General disorders     
Decreased CO2  9/86 (10.47%)  9 0/79 (0.00%)  0
Dizziness  8/86 (9.30%)  11 3/79 (3.80%)  4
Dysgeusia  13/86 (15.12%)  13 0/79 (0.00%)  0
Fatigue  14/86 (16.28%)  16 1/79 (1.27%)  1
Headache  13/86 (15.12%)  17 11/79 (13.92%)  16
Nasopharyngitis  5/86 (5.81%)  6 8/79 (10.13%)  11
Nausea  26/86 (30.23%)  30 10/79 (12.66%)  10
Vomiting  12/86 (13.95%)  13 3/79 (3.80%)  3
Hepatobiliary disorders     
Elevated ALT  6/86 (6.98%)  6 3/79 (3.80%)  4
Infections and infestations     
Sinusitis  3/86 (3.49%)  3 6/79 (7.59%)  7
Nervous system disorders     
Paresthesia  41/86 (47.67%)  51 5/79 (6.33%)  6
Respiratory, thoracic and mediastinal disorders     
Dyspnea  7/86 (8.14%)  8 2/79 (2.53%)  2
Skin and subcutaneous tissue disorders     
Rash  7/86 (8.14%)  8 2/79 (2.53%)  2
Surgical and medical procedures     
Post-LP syndrome  5/86 (5.81%)  9 6/79 (7.59%)  9
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Michael Wall
Organization: University of Iowa Hospitals and Clinics
Phone: 319-353-3942
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01003639     History of Changes
Other Study ID Numbers: NORDIC01
1U10EY017281-01A1 ( U.S. NIH Grant/Contract )
1U10EY017387-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 28, 2009
First Posted: October 29, 2009
Results First Submitted: March 3, 2016
Results First Posted: December 12, 2018
Last Update Posted: December 12, 2018