MedPath

IIH Pressure - a new treatment for raised brain pressure in Idiopathic Intracranial Hypertensio

Not Applicable
Completed
Conditions
Idiopathic intracranial hypertension
Nervous System Diseases
Neurological disorders
Registration Number
ISRCTN12678718
Lead Sponsor
niversity of Birmingham
Brief Summary

2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36320018/ Evaluation of telemetric intracranial pressure monitoring (added 03/11/2022) 2022 Preprint results in https://doi.org/10.1101/2022.05.24.22275518 Exenatide results (added 07/11/2022) 2022 Abstract results in https://doi.org/10.1186/s10194-022-01527-4 (added 05/08/2024) 2020 Other publications in https://pubmed.ncbi.nlm.nih.gov/33090189/ (added 05/08/2024) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/38487358/ Sub-study (added 05/08/2024)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
15
Inclusion Criteria

1. Female
2. Aged 18-60 years old
3. Diagnosed with IIH by the modified Dandy criteria
4. Active disease (papilloedema Frisen grade greater than 1)
5. Significantly raised ICP (greater than 25cm CSF)
6. No evidence of venous sinus thrombosis (documented normal MR Venogram of CT Venogram)
6. Able to provide informed consent

Exclusion Criteria

1. Aged less than 18 or older than 60 years
2. Pregnant or trying to conceive
3. Significant co-morbidity, such that in the opinion of the investigator it would not be in the participant’s best interest to participate in the trial
4. Addison’s or Cushing’s disease
5. Functioning CSF shunt/stent or optic nerve sheath fenestration
6. Currently using GLP-1 agonist or DPP-4 inhibitor
7. Surgical contra-indication
8. Concomitant therapy with acetazolomide, topiramate or diuretics (this can be discontinued 1 month prior to enrolment)
9. Inability to give informed consent e.g. due to cognitive impairment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath