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NCT05081128 · ClinicalTrials.gov registry record · NA
Efficacy in iNPH Shunting (PENS) Trial
A NA study of Idiopathic Normal Pressure Hydrocephalus (INPH), sponsored by Johns Hopkins University.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 17
- Study locations
NCT05081128: Active NA study of Idiopathic Normal Pressure Hydrocephalus (INPH), sponsored by Johns Hopkins University.
NCT05081128 is a NA study of Idiopathic Normal Pressure Hydrocephalus (INPH) that is active but no longer recruiting, run by Johns Hopkins University. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 17 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05081128, a NA study of Idiopathic Normal Pressure Hydrocephalus (INPH), is active but no longer recruiting, sponsored by Johns Hopkins University.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 17
- Study locations
Study Summary
The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.
Primary Outcome
Evaluation of CSF shunting in iNPH patients through a group comparison of change from baseline at three months between active and placebo-controlled groups, using the primary endpoint of gait velocity (in meters per second).
Conditions Studied
Interventions
- DEVICE programmable CSF shunt valve
Study Locations (17)
California
- University of California, Davis - Davis
- University of Southern California - Los Angeles
- Pacific Neuroscience Institute - Santa Monica
New York
- New York University Langone Health - New York
- Mount Sinai Health System - New York
Other
- University of British Columbia - Vancouver
- Umeå University - Umeå
Florida
- University of South Florida - Tampa
Georgia
- Emory University - Atlanta
Indiana
- Indiana University - Indianapolis
Maryland
- Johns Hopkins University - Baltimore
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-05-18 |
| Est. Completion | 2027-08 |
| Phase | NA |
What the registry record for NCT05081128 still lists
NCT05081128 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Idiopathic Normal Pressure Hydrocephalus (INPH) appearing as the primary indexed condition, and to 1 intervention - of which programmable CSF shunt valve is the first listed.
NCT05081128 lists 17 locations in 13 states (California, New York, Other).
Frequently Asked Questions
What is clinical trial NCT05081128 about?
NCT05081128 is a clinical study titled "Efficacy in iNPH Shunting (PENS) Trial". The Placebo-Controlled Efficacy in Idiopathic Normal Pressure Hydrocephalus (iNPH) Shunting (PENS) trial is a multi-center blinded, randomized, placebo-controlled design investigation of cerebrospinal fluid (CSF) shunt surgery to study the shunt efficacy in iNPH patients.
What is the current status of trial NCT05081128?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2022-05-18. Estimated completion is 2027-08.
What conditions does trial NCT05081128 study?
This clinical trial studies the following conditions: Idiopathic Normal Pressure Hydrocephalus (INPH).
What interventions are being tested in trial NCT05081128?
The interventions under investigation include: programmable CSF shunt valve (DEVICE).
Who is sponsoring clinical trial NCT05081128?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05081128 being conducted?
This trial has 17 study locations across California, Florida, Georgia, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05081128's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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