Study S001970

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

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05347147
Acronym: IIH EVOLVE
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: QUADRUPLE
Status: TERMINATED
Enrollment: 14
Start: 2022-11-18
Primary completion: 2023-09-18
Lead sponsor: Invex Therapeutics Ltd.
Conditions: Idiopathic Intracranial Hypertension
Interventions: DRUG:Presendin; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: NO

Registered primary outcomes

Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP [Baseline to Week 24]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0013333	Letter: GLP-1 Receptor Agonists: Beyond Diabetes-What the Neurosurgeon Needs to Know. Patel SA, Neurosurgery	2024	Randomized trial	PMID 39360816 DOI	cites ClinicalTrials.gov:NCT05347147