IIH EVOLVE
Research type
Research Study
Full 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
IRAS ID
1005037
Contact name
Carol Parish
Contact email
Sponsor organisation
Invex Therapeutics Ltd.
Eudract number
2021-006664-24
Clinicaltrials.gov Identifier
Research summary
Idiopathic intracranial hypertension (IIH) is a condition characterised by raised intracranial pressure (ICP) with no known cause. IIH is a rare condition however is increasing with rising obesity trends. 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 how safe and effective Presendin is in the reduction of ICP in patients with IIH. Presendin is a modified release formulation of a drug called exenatide which is currently used in the management of type 2 diabetes.
Patients will be randomly allocated in a ratio of 1:1 to receive either Presendin or placebo (dummy drug with no active ingredient) as a weekly injection for 24 weeks. Neither the participant not the study doctor will know which drug they are receiving.
This study will involve 240 patients with IIH globally.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0378
Date of REC Opinion
16 Jun 2022
REC opinion
Further Information Favourable Opinion