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A Trial to Determine the Efficacy and Safety of Presendin in IIH — IIH EVOLVE  

Idiopathic Intracranial Hypertension Clinical Trial

Official title:
A Phase III Randomised, Placebo-controlled, Double-blind, Multi-centre, Clinical Trial to Determine the Efficacy and Safety of Presendin in Idiopathic Intracranial Hypertension

Clinical Trial Summary

Idiopathic intracranial hypertension (IIH) has significant associated morbidity and reduced quality of life. There is a significant risk of visual loss and patients also typically suffer with chronic disabling headaches. This trial has been designed to evaluate the efficacy and safety of a new formulation of exenatide (Presendin) in the reduction of intracranial pressure (ICP) in patients with IIH.

Clinical Trial Description

Patients will be provided with training on the self-administration of the trial medication from the site trial co-ordinator. A 1-week screening period will be followed by a 24-week randomised double-blind treatment period in which patients will be randomised (1:1) to receive a subcutaneous (SC) dose of either Presendin (containing 2 mg of exenatide [active group]) or matching placebo (placebo group), self-administered once weekly. At the end of the randomised treatment period (Week 24), all patients will have an end-of-treatment clinic visit. Five weeks after the end-of-treatment visit, an end-of-trial safety follow-up telephone visit will be performed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05347147
Study type Interventional
Source Invex Therapeutics Ltd.
Contact
Status Terminated
Phase Phase 3
Start date November 18, 2022
Completion date October 20, 2023
View Details
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