NCT05347147

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Invex Therapeutics Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Idiopathic Intracranial Hypertension

Interventions

Type	Name	Description
DRUG	Presendin	Presendin is supplied as 2 parts, one vial consisting of a drug part (white or greyish white powder in a clear vial) and one pre-filled syringe containing the diluent part (colourless liquid). The drug part is suspended in the diluent part solution and administered SC as a suspension.
DRUG	Placebo	Placebo is supplied as 2 parts (visually identical to the Presendin vial and pre-filled diluent syringe). The drug part will exclude the active pharmaceutical ingredient (exenatide acetate) and the diluent part will be the same as the active treatment diluent. The drug part is suspended in the diluent part solution and administered SC as a suspension.

Timeline

• Start date: 2022-11-18
• Primary completion: 2023-09-18
• Completion: 2023-10-20
• First posted: 2022-04-26
• Last updated: 2024-04-24
• Results posted: 2024-04-24

Locations

24 sites across 6 countries: United States, Australia, Germany, Israel, New Zealand, United Kingdom

Regulatory

• FDA-regulated drug study