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Presendin for Pseudotumor Cerebri (IIH EVOLVE Trial)
Phase 3
Waitlist Available
Research Sponsored by Invex Therapeutics Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24
Awards & highlights
IIH EVOLVE Trial Summary
This trial is testing a new medicine to see if it can help people with a condition that can cause headaches and vision loss.
Eligible Conditions
- Pseudotumor Cerebri
IIH EVOLVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Secondary outcome measures
Change in Perimetric Mean Deviation (PMD), Measured by Humphrey Visual Field (HVF) Analysis (24-2 SITA-Standard), Where a Larger Negative Result Indicates Greater Visual Loss
Headache Severity
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
+8 moreIIH EVOLVE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PresendinExperimental Treatment1 Intervention
2.0 mg
Group II: PlaceboPlacebo Group1 Intervention
Find a Location
Who is running the clinical trial?
University Hospitals Birmingham Neuro Ophthalmology Reading Centre, Birmingham, UKUNKNOWN
Iowa Visual Field Reading Centre, Iowa, USAUNKNOWN
Invex Therapeutics Ltd.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a recent history of drug or alcohol abuse or dependence, which the doctor thinks could put you at risk.The doctor thinks that it is not safe for you to have a lumbar puncture done.You have eye diseases that cause vision loss in the eye being studied, except for refractive error. A group of experts called the IAC will decide if there is any uncertainty.You have had at least two headache days in the week before screening, and you must have at least two headache days during the screening period.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Presendin
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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