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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
Pivotal Trial

Summary

This trial is testing a new injectable drug called Presendin to help patients with high skull pressure due to IIH. The drug aims to reduce brain fluid pressure, which may relieve headaches and protect vision.

Eligible Conditions
  • Pseudotumor Cerebri

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in ICP From Baseline to Week 24 Measured by Lumbar Puncture (LP), Where a Higher LP Value Indicates Greater ICP
Secondary study objectives
Headache Severity
Number of MHD Responders (Defined as a ≥50% Reduction in MHD)
Number of Moderate to Severe MHD
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05347147 — Phase 3
Pseudotumor Cerebri Research Study Groups: Placebo, Presendin
Pseudotumor Cerebri Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05347147 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05347147 — Phase 3
~5 spots leftby Oct 2025