Tirzepatide in Idiopathic Intracranial Hypertension Trial
Recruiting
Phase 4
Interventional Study
Idiopathic Intracranial Hypertension (IIH)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 60
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Duke University · Other
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
About This Trial
This will be a randomized, double-blind, parallel, placebo-controlled trial of 60 participants. The primary analysis will be a statistical comparison of the estimates of the mean difference in the 12-month change in intracranial pressure (ICP) between participants assigned to the tirzepatide and Placebo arms in 1:1 randomization using the intention-to-treat (ITT) population. Hypothesis testing wil…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Signs and symptoms of increased intracranial pressure:
1. headaches, tinnitus, visual obscurations, papilledema;
2. absence of localizing findings on neurological examination (except for VI nerve palsy);
3. no secondary causes identified on imaging, e.g., hydrocepha…
Contacts