Idiopathic intracranial hypertension Nervous System Diseases Neurological disorders
Conditions
Interventions
The main part of the trial has two arms, active treatment and placebo. The second part of the trial is single arm and open to all participants on the main trial.
First part of the study:
The randomis
Sponsors
University of Birmingham
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in Intracranial pressure (ICP) measured by telemetric ICP catheter between baseline and 24 hours post drug administration 2. Change in ICP measured by telemetric ICP catheter between baseline and end of trial visit 3. Change in ICP measured by telemetric ICP catheter between baseline and 2.5 hours post administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Biological effects of exenatide measured using blood tests at 24 h, 2 and 12 weeks 2. Headaches measured using severity scores at 24 h, 2 and 12 weeks 3. Quality of life measured using SF-36 at baseline and 12 weeks 4. CSF exenatide levels measured by assay at two and a half, six and 11 hours | — |
Countries
England, United Kingdom
Contacts
Public ContactJames Mitchell
Outcome results
None listed