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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

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

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 moderate to severe MHD

+8 more

IIH EVOLVE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PresendinExperimental Treatment1 Intervention

2.0 mg

Group II: PlaceboPlacebo Group1 Intervention

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Find a Location

Who is running the clinical trial?

Invex Therapeutics Ltd.Lead Sponsor

Premier Research Group plcIndustry Sponsor

62 Previous Clinical Trials

69,345 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian institutions conducting clinical research on this particular topic?

"Currently, 8 sites are running this experiment in destinations such as Houston, Liverpool and Sydney to name a few. It is wise for potential participants to select the closest site so that travel requirements are minimized."

Answered by AI

What is the upper limit for enrolment in this clinical trial?

"The trial sponsor, Invex Therapeutics Ltd., must enlist 240 compliant patients to complete the research. For this reason, Neuro-Eye Clinical Trials Inc in Houston and Liverpool Hospital in New South Wales are two of many sites participating in the study."

Answered by AI

What potential hazards could Presendin pose to individuals?

"According to our team at Power, Presendin has attained a safety rating of 3 on the scale due to its Phase 3 clinical trial results – implying that there is ample evidence in support of efficacy and multiple rounds demonstrating its security."

Answered by AI

Is admission to this research still available?

"As exhibited on clinicaltrials.gov, the trial is currently recruiting participants to its cohort; this project was initially posted November 18th 2022 and recently updated March 29th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Trial to Determine the Efficacy and Safety of Presendin in IIH

2022. "A Trial to Determine the Efficacy and Safety of Presendin in IIH". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05347147.