NCT05347147 - A Trial to Determine the Efficacy and Safety of Presendin in IIH | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 18, 2022

Primary Completion Date

September 18, 2023

Study Completion Date

October 20, 2023

Conditions

Idiopathic Intracranial Hypertension

Interventions

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.

Trial Locations (24)

2000

Sydney Eye Hospital, Sydney

2170

Liverpool Hospital, Liverpool

3004

Alfred Health - The Alfred Centre, Melbourne

5056

Vision SA, Kent Town

10075

New York Eye and Ear Infirmary of Mount Sinai, New York

33136

University of Miami Leonard M. Miller School of Medicine (UMMSM) - Bascom Palmer Eye Institute, Miami

37232

Vanderbilt Eye Institute, Nashville

48149

University Hospital Muenster, Department Ophthalmology Clinical Trials in Ophthalmology (CTO), Münster

53105

University Hospital Bonn, Bonn

55131

Universitaetsmedizin Mainz, Mainz

55455

University of Minnesota Health, Minneapolis

75390

The University of Texas Southwestern Medical Center, Dallas

77074

Neuro-Eye Clinical Trials, Inc, Houston

79106

Universitätsklinikum Freiburg, Freiburg im Breisgau

80045

UCHealth Sue Anschutz-Rodgers Eye Center - Anschutz Medical Campus, Aurora

91120

Hadassah Medical Center - Ein Karem, Jerusalem

1528001

Pade Medical Center (Poriya), Tiberias

3109601

Rambam Medical Center, Haifa

3339419

Bnai Zion Medical Center, Haifa

5822012

The Edith Wolfson Medical Center, Holon

9103102

Shaare Zedek Medical Center, Jerusalem

0624

New Zealand Clinical Research (Aukland), Auckland

B15 2GW

University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital Birmingham, Birmingham

SE1 7EH

Guy's and St Thomas' NHS Foundation Trust, London