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
Location: See all (24) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years at the time of consent.

• Diagnosis of new IIH by consensus criteria, including normal structural brain imaging (excluding features of raised ICP and incidentalomas), including either magnetic resonance venography or computed tomographic venography to exclude thrombosis and no evidence of a secondary causes of raised ICP.

• Newly diagnosed patients with screening commenced no more than 4 weeks after the diagnostic LP.

• Lumbar puncture opening pressure ≥25 cm cerebrospinal fluid (CSF) at diagnosis.

• Presence of bilateral papilloedema (Frisén grade ≥1). Verification of papilloedema by the OCT Reading Centre. Where there is uncertainty fundus photography and/or ultrasound scan (B scan) of the optic nerves should be conducted for evaluation by the Independent Adjudication Committee (IAC).

• Perimetric Mean Deviation defined as between -2 to -7 decibels (dB) in at least one eye. Eyes meeting this criterion will defined as 'study eyes'.

• Reproducible visual loss present on automated perimetry including no more than 15% false positive responses (reliability confirmed by the Visual Field Reading Centre) in study eyes.

• Two or more headache days over the 7-day period prior to screening and also the patient must meet this criterion during the 7-day screening period.

• Females of childbearing potential must have a negative pregnancy test and must agree to use a highly effective birth control method (failure rate less than 1% per year when used consistently and correctly) during the whole trial duration including the last follow-up visit (12 weeks after ceasing drug). Female patients who are lactating must agree to stop breast-feeding OR Female patients of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea \[in questionable cases a blood sample with simultaneous follicle stimulation hormone 25-140 IE/L and oestradiol \<200 pmol/L is confirmatory\]).

⁃ Male patients with a female partner of childbearing potential must commit to practice methods of contraception (e.g., condom, vasectomy) and abstain from sperm donation during the trial including the last follow-up visit (12 weeks after ceasing drug). Their partners, if they are women of childbearing potential, must agree to practice contraception and to use a highly effective method of contraception during the trial, including the last follow-up visit (12 weeks after ceasing drug).

⁃ Able to provide written informed consent.

Locations
United States
Colorado
UCHealth Sue Anschutz-Rodgers Eye Center - Anschutz Medical Campus
Aurora
Florida
University of Miami Leonard M. Miller School of Medicine (UMMSM) - Bascom Palmer Eye Institute
Miami
Minnesota
University of Minnesota Health
Minneapolis
New York
New York Eye and Ear Infirmary of Mount Sinai
New York
Tennessee
Vanderbilt Eye Institute
Nashville
Texas
The University of Texas Southwestern Medical Center
Dallas
Neuro-Eye Clinical Trials, Inc
Houston
Other Locations
Australia
Vision SA
Kent Town
Liverpool Hospital
Liverpool
Alfred Health - The Alfred Centre
Melbourne
Sydney Eye Hospital
Sydney
Germany
University Hospital Bonn
Bonn
Universitätsklinikum Freiburg
Freiburg Im Breisgau
Universitaetsmedizin Mainz
Mainz
University Hospital Muenster, Department Ophthalmology Clinical Trials in Ophthalmology (CTO)
Münster
Israel
Bnai Zion Medical Center
Haifa
Rambam Medical Center
Haifa
The Edith Wolfson Medical Center
Holon
Hadassah Medical Center - Ein Karem
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Pade Medical Center (Poriya)
Tiberias
New Zealand
New Zealand Clinical Research (Aukland)
Auckland
United Kingdom
University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham
Birmingham
Guy's and St Thomas' NHS Foundation Trust
London
Time Frame
Start Date: 2022-11-18
Completion Date: 2023-10-20
Participants
Target number of participants: 14
Treatments
Experimental: Presendin
2.0 mg
Placebo_comparator: Placebo
Sponsors
Collaborators: University Hospital Birmingham, University of Iowa, Premier Research
Leads: Invex Therapeutics Ltd.

This content was sourced from clinicaltrials.gov