Idiopathic Intracranial Hypertension (IIH)NCT06913712
BMI in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment
An observational study of Idiopathic Intracranial Hypertension (IIH), run by University of Valencia at 1 site in Spain.
Trial summary
1. To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments. 2. To establish the BMI at which this disease occurs. 3. To establish how much the BMI must be reduced to cure this disease. 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Intracranial Hypertension (IIH)
- What is being tested?
- Weight loss without pharmacotherapy
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 27 Jun 2024to 1 May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is designed to be a retrospective-prospective cohort study. Data was collected from all retrospective patients attended in the last 10 years by the Neurosurgery department at Hospital General Universitario de Valencia who presented idiopathic intracranial hypertension (IIH) and were accepted to participate. Data were extracted and reviewed from the patient's medical records.
Who may be able to join
- Adults aged 18 years and older at the time of enrollment. There is no upper age limit to ensure inclusivity across age ranges.
- A confirmed diagnosis of Idiopathic Intracranial Hypertension, established according to the Dandy criteria.
- The diagnostic process must exclude other potential causes of increased intracranial pressure as detailed in the 'Diagnosis' section, ensuring an accurate identification of idiopathic cases.
Who cannot join
- A diagnosis other than IIH, specifically: tension-type headache, Chiari I malformation, or any other headache disorder unrelated to IIH.
- The presence of secondary causes of increased intracranial pressure (e.g., structural brain abnormalities, venous sinus thrombosis, or medication-induced factors).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consorcio Hospital General Universitario de Valencia
Valencia, Valencia, 46015
Vicente Vanaclocha, Professor, +34 963 13 18 00 ext. 438500, vivava@uv.es
About this study
Official title: Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study
- To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments.
- To establish the BMI at which this disease occurs.
- To establish how much the BMI must be reduced to cure this disease.
- To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion
Read the detailed description
There is unanimity that one of the causes of benign intracranial hypertension is obesity. However, there is no agreement on the upper limit of BMI above which this disease occurs or the lower limit above which it is cured. People affected by this disease often have extreme difficulty losing weight and it is not uncommon for them to have followed various diets over the years to lose weight. In general, patients prefer to take medication or to undergo surgery with the implantation of a cerebrospinal fluid diversion system that does not force them to sacrifice following a strict diet. Unfortunately, those who do not manage to lose weight noticeably present repeated complications due to malfunction of the CSF diversion system with headaches and a progressive loss of visual acuity. Among other reasons, it must be considered that cerebrospinal fluid diversion systems work by pressure gradient. Since obesity increases the pressure inside the peritoneal cavity, these shunt systems will be ineffective because they will not be able to drain even if the pressure of the shunt valve is diminished to levels below 6 mm Hg.
The aim of this study is to find out what the specific BMI goal should be for each patient in particular and to be able to make them aware of this so that they make an effort and achieve it. Patients are referred to Endocrinology to be recommended the diet to follow. In some cases, bariatric surgery is used. Still, as it does not require effort or awareness on the part of these people, it is not uncommon for them to gain weight again and for benign intracranial hypertension to recur. The usual thing is that their evolution is torpid and the repeated therapeutic attempts are fruitless or plagued by complications. Weight loss using medication such as Ozempic (Semaglutide) is not accepted internationally nor contemplated by the Endocrinology Service of the General University Hospital of Valencia. On the one hand, it has no indication and on the other hand, the possible complications are not known. In addition, patients who take it on their own initially lose weight, but when they stop taking the medication they quickly regain the lost weight as a result of not having adopted healthy eating habits.
- Being tested
- Weight loss without pharmacotherapy
- Keywords
- Idiopathic Intracranial Hypertension, Body Mass Index, Lumboperitoneal Shunt, Ventriculoperitoneal Shunt, Acetazolamide
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss without pharmacotherapyOther
The study will record the weight of the patients with Idiopathic Intracranial Hypertension every three months. It will correlate with the response to the different treatment modalities (weight loss with no other intervention, diuretic drugs (acetazolamide), lumboperitoneal shunt, or ventriculoperitoneal shunt). No medication will be provided to help lose weight.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Idiopathic Intracranial Hypertension | Patients with Idiopathic Intracranial Hypertension Receives: Other: Weight loss without pharmacotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
BMI evolution in patients with benign intracranial hypertension and its relationship with the evolution of the patient's symptoms
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start27 Jun 2024
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Intracranial Hypertension (IIH)Studies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vicente Vanaclocha, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913712
- Sponsor's protocol ID
- V 07/06/2024
- Status last verified
- Apr 2026
- First submitted
- 12 Jan 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kleinschmidt JJ, Digre KB, Hanover R. Idiopathic intracranial hypertension: relationship to depression, anxiety, and quality of life. Neurology. 2000 Jan 25;54(2):319-24. doi: 10.1212/wnl.54.2.319.
PubMed 10668690Mollan SP, Mitchell JL, Yiangou A, Ottridge RS, Alimajstorovic Z, Cartwright DM, Hickman SJ, Markey KA, Singhal R, Tahrani AA, Frew E, Brock K, Sinclair AJ. Association of Amount of Weight Lost After Bariatric Surgery With Intracranial Pressure in Women With Idiopathic Intracranial Hypertension. Neurology. 2022 Sep 13;99(11):e1090-e1099. doi: 10.1212/WNL.0000000000200839. Epub 2022 Jul 5.
PubMed 35790425Ko MW, Chang SC, Ridha MA, Ney JJ, Ali TF, Friedman DI, Mejico LJ, Volpe NJ, Galetta SL, Balcer LJ, Liu GT. Weight gain and recurrence in idiopathic intracranial hypertension: a case-control study. Neurology. 2011 May 3;76(18):1564-7. doi: 10.1212/WNL.0b013e3182190f51.
PubMed 21536635Aguiar M, Frew E, Mollan SP, Mitchell JL, Ottridge RS, Alimajstorovic Z, Yiangou A, Singhal R, Tahrani AA, Sinclair AJ. The Health Economic Evaluation of Bariatric Surgery Versus a Community Weight Management Intervention Analysis from the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT). Life (Basel). 2021 Apr 30;11(5):409. doi: 10.3390/life11050409.
PubMed 33946177Elliot L, Frew E, Mollan SP, Mitchell JL, Yiangou A, Alimajstorovic Z, Ottridge RS, Wakerley BR, Thaller M, Grech O, Singhal R, Tahrani AA, Harrison M, Sinclair AJ, Aguiar M. Cost-effectiveness of bariatric surgery versus community weight management to treat obesity-related idiopathic intracranial hypertension: evidence from a single-payer healthcare system. Surg Obes Relat Dis. 2021 Jul;17(7):1310-1316. doi: 10.1016/j.soard.2021.03.020. Epub 2021 Mar 30.
PubMed 33952427Mahendran V, Ricart P, Levine F, White E, Abolghasemi-Malekabadi K, Williams M, Wadley MS, Perry A, Robinson SJ. Bariatric Surgery as a Viable Treatment for Idiopathic Intracranial Hypertension: a Case Series and Review of Literature. Obes Surg. 2021 Oct;31(10):4386-4391. doi: 10.1007/s11695-021-05587-4. Epub 2021 Jul 28.
PubMed 34322839Mollan SP, Mitchell JL, Ottridge RS, Aguiar M, Yiangou A, Alimajstorovic Z, Cartwright DM, Grech O, Lavery GG, Westgate CSJ, Vijay V, Scotton W, Wakerley BR, Matthews TD, Ansons A, Hickman SJ, Benzimra J, Rick C, Singhal R, Tahrani AA, Brock K, Frew E, Sinclair AJ. Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):678-686. doi: 10.1001/jamaneurol.2021.0659.
PubMed 33900360Westgate CSJ, Markey K, Mitchell JL, Yiangou A, Singhal R, Stewart P, Tomlinson JW, Lavery GG, Mollan SP, Sinclair AJ. Increased systemic and adipose 11beta-HSD1 activity in idiopathic intracranial hypertension. Eur J Endocrinol. 2022 Jul 4;187(2):323-333. doi: 10.1530/EJE-22-0108. Print 2022 Aug 1.
PubMed 35584002Abu-Abeid A, Bendayan A, Tome J, Lessing Y, Eldar SM, Keidar A, Dayan D. Long Term Effects of Metabolic and Bariatric Surgery on Idiopathic Intracranial Hypertension. Obes Surg. 2023 Aug;33(8):2615-2619. doi: 10.1007/s11695-023-06696-y. Epub 2023 Jun 23.
PubMed 37351765Okida LF, Salimi T, Aleman R, Funes DR, Frieder J, Gutierrez D, Montorfano L, Lo Menzo E, Szomstein S, Rosenthal RJ. Midterm benefits of metabolic surgery on symptom remission and medication use in patients with pseudotumor cerebri. Surgery. 2023 Apr;173(4):904-911. doi: 10.1016/j.surg.2022.11.031. Epub 2022 Dec 20.
PubMed 36549974Kupersmith MJ, Gamell L, Turbin R, Peck V, Spiegel P, Wall M. Effects of weight loss on the course of idiopathic intracranial hypertension in women. Neurology. 1998 Apr;50(4):1094-8. doi: 10.1212/wnl.50.4.1094.
PubMed 9566400Greener DL, Akarca D, Durnford AJ, Ewbank F, Buckland GR, Hempenstall J. Idiopathic Intracranial Hypertension: Shunt Failure and the Role of Obesity. World Neurosurg. 2020 May;137:e83-e88. doi: 10.1016/j.wneu.2020.01.040. Epub 2020 Jan 16.
PubMed 31954904Wong R, Madill SA, Pandey P, Riordan-Eva P. Idiopathic intracranial hypertension: the association between weight loss and the requirement for systemic treatment. BMC Ophthalmol. 2007 Sep 21;7:15. doi: 10.1186/1471-2415-7-15.
PubMed 17888152Sinclair AJ, Burdon MA, Nightingale PG, Ball AK, Good P, Matthews TD, Jacks A, Lawden M, Clarke CE, Stewart PM, Walker EA, Tomlinson JW, Rauz S. Low energy diet and intracranial pressure in women with idiopathic intracranial hypertension: prospective cohort study. BMJ. 2010 Jul 7;341:c2701. doi: 10.1136/bmj.c2701.
PubMed 20610512Weil R, Kovacs B, Miller N, McDermott MP, Wall M, Kupersmith M, Pi-Sunyer FX; NORDIC Idiopathic Intracranial Hypertension Study Group. A 6-month telephone-based weight loss intervention in overweight and obese subjects with idiopathic intracranial hypertension. Obes Sci Pract. 2016 Apr 5;2(2):95-103. doi: 10.1002/osp4.34. eCollection 2016 Jun.
PubMed 29071096
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study
- ClinicalTrials.gov ID
- NCT06913712
- Acronym / sponsor ID
- V 07/06/2024
- Keywords
- Idiopathic Intracranial Hypertension, Body Mass Index, Lumboperitoneal Shunt, Ventriculoperitoneal Shunt, Acetazolamide
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 27 Jun 2024 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To establish the correlation between the evolution of the body mass index in benign intracranial hypertension and the response to treatments.
- To establish the BMI at which this disease occurs.
- To establish how much the BMI must be reduced to cure this disease.
- To assess the evolution and response to treatments of sick people who DO NOT reduce or even continue to increase their BMI despite treatment with Acetazolamide or a possible CSF diversion
Detailed description
There is unanimity that one of the causes of benign intracranial hypertension is obesity. However, there is no agreement on the upper limit of BMI above which this disease occurs or the lower limit above which it is cured. People affected by this disease often have extreme difficulty losing weight and it is not uncommon for them to have followed various diets over the years to lose weight. In general, patients prefer to take medication or to undergo surgery with the implantation of a cerebrospinal fluid diversion system that does not force them to sacrifice following a strict diet. Unfortunately, those who do not manage to lose weight noticeably present repeated complications due to malfunction of the CSF diversion system with headaches and a progressive loss of visual acuity. Among other reasons, it must be considered that cerebrospinal fluid diversion systems work by pressure gradient. Since obesity increases the pressure inside the peritoneal cavity, these shunt systems will be ineffective because they will not be able to drain even if the pressure of the shunt valve is diminished to levels below 6 mm Hg.
The aim of this study is to find out what the specific BMI goal should be for each patient in particular and to be able to make them aware of this so that they make an effort and achieve it. Patients are referred to Endocrinology to be recommended the diet to follow. In some cases, bariatric surgery is used. Still, as it does not require effort or awareness on the part of these people, it is not uncommon for them to gain weight again and for benign intracranial hypertension to recur. The usual thing is that their evolution is torpid and the repeated therapeutic attempts are fruitless or plagued by complications. Weight loss using medication such as Ozempic (Semaglutide) is not accepted internationally nor contemplated by the Endocrinology Service of the General University Hospital of Valencia. On the one hand, it has no indication and on the other hand, the possible complications are not known. In addition, patients who take it on their own initially lose weight, but when they stop taking the medication they quickly regain the lost weight as a result of not having adopted healthy eating habits.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Idiopathic Intracranial Hypertension | – | Other: Weight loss without pharmacotherapyPatients with Idiopathic Intracranial Hypertension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is designed to be a retrospective-prospective cohort study. Data was collected from all retrospective patients attended in the last 10 years by the Neurosurgery department at Hospital General Universitario de Valencia who presented idiopathic intracranial hypertension (IIH) and were accepted to participate. Data were extracted and reviewed from the patient's medical records.
Key inclusion criteria (3 listed)
- Adults aged 18 years and older at the time of enrollment. There is no upper age limit to ensure inclusivity across age ranges.
- A confirmed diagnosis of Idiopathic Intracranial Hypertension, established according to the Dandy criteria.
- The diagnostic process must exclude other potential causes of increased intracranial pressure as detailed in the 'Diagnosis' section, ensuring an accurate identification of idiopathic cases.
Key exclusion criteria (2 listed)
- A diagnosis other than IIH, specifically: tension-type headache, Chiari I malformation, or any other headache disorder unrelated to IIH.
- The presence of secondary causes of increased intracranial pressure (e.g., structural brain abnormalities, venous sinus thrombosis, or medication-induced factors).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss without pharmacotherapyThe study will record the weight of the patients with Idiopathic Intracranial Hypertension every three months. It will correlate with the response to the different treatment modalities (weight loss with no other intervention, diuretic drugs (acetazolamide), lumboperitoneal shunt, or ventriculoperitoneal shunt). No medication will be provided to help lose weight. | Other | Patients with Idiopathic Intracranial Hypertension |
Primary outcome
Response to treatment
Time frame: Through study completion, an average of 1 year
BMI evolution in patients with benign intracranial hypertension and its relationship with the evolution of the patient's symptoms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 10668690Kleinschmidt JJ, Digre KB, Hanover R. Idiopathic intracranial hypertension: relationship to depression, anxiety, and quality of life. Neurology. 2000 Jan 25;54(2):319-24. doi: 10.1212/wnl.54.2.319.
- Background: PubMed 35790425Mollan SP, Mitchell JL, Yiangou A, Ottridge RS, Alimajstorovic Z, Cartwright DM, Hickman SJ, Markey KA, Singhal R, Tahrani AA, Frew E, Brock K, Sinclair AJ. Association of Amount of Weight Lost After Bariatric Surgery With Intracranial Pressure in Women With Idiopathic Intracranial Hypertension. Neurology. 2022 Sep 13;99(11):e1090-e1099. doi: 10.1212/WNL.0000000000200839. Epub 2022 Jul 5.
- Background: PubMed 21536635Ko MW, Chang SC, Ridha MA, Ney JJ, Ali TF, Friedman DI, Mejico LJ, Volpe NJ, Galetta SL, Balcer LJ, Liu GT. Weight gain and recurrence in idiopathic intracranial hypertension: a case-control study. Neurology. 2011 May 3;76(18):1564-7. doi: 10.1212/WNL.0b013e3182190f51.
- Background: PubMed 33946177Aguiar M, Frew E, Mollan SP, Mitchell JL, Ottridge RS, Alimajstorovic Z, Yiangou A, Singhal R, Tahrani AA, Sinclair AJ. The Health Economic Evaluation of Bariatric Surgery Versus a Community Weight Management Intervention Analysis from the Idiopathic Intracranial Hypertension Weight Trial (IIH:WT). Life (Basel). 2021 Apr 30;11(5):409. doi: 10.3390/life11050409.
- Background: PubMed 33952427Elliot L, Frew E, Mollan SP, Mitchell JL, Yiangou A, Alimajstorovic Z, Ottridge RS, Wakerley BR, Thaller M, Grech O, Singhal R, Tahrani AA, Harrison M, Sinclair AJ, Aguiar M. Cost-effectiveness of bariatric surgery versus community weight management to treat obesity-related idiopathic intracranial hypertension: evidence from a single-payer healthcare system. Surg Obes Relat Dis. 2021 Jul;17(7):1310-1316. doi: 10.1016/j.soard.2021.03.020. Epub 2021 Mar 30.
- Background: PubMed 34322839Mahendran V, Ricart P, Levine F, White E, Abolghasemi-Malekabadi K, Williams M, Wadley MS, Perry A, Robinson SJ. Bariatric Surgery as a Viable Treatment for Idiopathic Intracranial Hypertension: a Case Series and Review of Literature. Obes Surg. 2021 Oct;31(10):4386-4391. doi: 10.1007/s11695-021-05587-4. Epub 2021 Jul 28.
- Background: PubMed 33900360Mollan SP, Mitchell JL, Ottridge RS, Aguiar M, Yiangou A, Alimajstorovic Z, Cartwright DM, Grech O, Lavery GG, Westgate CSJ, Vijay V, Scotton W, Wakerley BR, Matthews TD, Ansons A, Hickman SJ, Benzimra J, Rick C, Singhal R, Tahrani AA, Brock K, Frew E, Sinclair AJ. Effectiveness of Bariatric Surgery vs Community Weight Management Intervention for the Treatment of Idiopathic Intracranial Hypertension: A Randomized Clinical Trial. JAMA Neurol. 2021 Jun 1;78(6):678-686. doi: 10.1001/jamaneurol.2021.0659.
- Background: PubMed 35584002Westgate CSJ, Markey K, Mitchell JL, Yiangou A, Singhal R, Stewart P, Tomlinson JW, Lavery GG, Mollan SP, Sinclair AJ. Increased systemic and adipose 11beta-HSD1 activity in idiopathic intracranial hypertension. Eur J Endocrinol. 2022 Jul 4;187(2):323-333. doi: 10.1530/EJE-22-0108. Print 2022 Aug 1.
- Background: PubMed 37351765Abu-Abeid A, Bendayan A, Tome J, Lessing Y, Eldar SM, Keidar A, Dayan D. Long Term Effects of Metabolic and Bariatric Surgery on Idiopathic Intracranial Hypertension. Obes Surg. 2023 Aug;33(8):2615-2619. doi: 10.1007/s11695-023-06696-y. Epub 2023 Jun 23.
- Background: PubMed 36549974Okida LF, Salimi T, Aleman R, Funes DR, Frieder J, Gutierrez D, Montorfano L, Lo Menzo E, Szomstein S, Rosenthal RJ. Midterm benefits of metabolic surgery on symptom remission and medication use in patients with pseudotumor cerebri. Surgery. 2023 Apr;173(4):904-911. doi: 10.1016/j.surg.2022.11.031. Epub 2022 Dec 20.
- Background: PubMed 9566400Kupersmith MJ, Gamell L, Turbin R, Peck V, Spiegel P, Wall M. Effects of weight loss on the course of idiopathic intracranial hypertension in women. Neurology. 1998 Apr;50(4):1094-8. doi: 10.1212/wnl.50.4.1094.
- Background: PubMed 31954904Greener DL, Akarca D, Durnford AJ, Ewbank F, Buckland GR, Hempenstall J. Idiopathic Intracranial Hypertension: Shunt Failure and the Role of Obesity. World Neurosurg. 2020 May;137:e83-e88. doi: 10.1016/j.wneu.2020.01.040. Epub 2020 Jan 16.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Intracranial Hypertension (IIH)
RecruitingPhase 4
Tirzepatide in Idiopathic Intracranial Hypertension Trial
Idiopathic Intracranial Hypertension (IIH)
Not yet recruitingPhase 3
Eptinezumab for Chronic Headache in Idiopathic Intracranial Hypertension
Idiopathic Intracranial Hypertension (IIH)
Not yet recruiting
Stenting Of Symptomatic Cerebral siNus stenosIs With the laserCut Self-expanding SILANCE Stent
Idiopathic Intracranial Hypertension (IIH)
Recruiting
Venous Stenting Evaluation in Patients With Intracranial Hypertension Under Long-term Acetazolamide
Idiopathic Intracranial Hypertension (IIH)
Recruiting
IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness
IIH - Idiopathic Intracranial Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Intracranial Hypertension (IIH), run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicente Vanaclocha, Professor (+ 34 963 13 18 00 ext. 438500, vivava@uv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06913712, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.