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Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

Study acronym: PATCHES
StatusEnrolling by Invitation
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Henrik Schytz to Danish Headache Centerv2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to learn about the effects of a low-pressure environment on the brain in patients with intracranial hypotension and to potentially improve diagnostics and treatment of this condition. The primary objective will be: To investigate the change in clinical biomarkers measured before and after successful treatment. The secondary objectives will be: To investigate if clinical biomarkers can predict the outcome of treatment. Participants undergoing standard treatment for intracranial hypotension will undergo additional examinations and surveys and will be followed up for a year for the study.
Trial Details
NCT Number NCT06805591
Lead Sponsor Danish Headache Center
Conditions
(from sponsor)		 Spontaneous Intracranial Hypotension, Intracranial Hypotension, Post-Lumbar Puncture Headache
Related terms Intracranial Hypotension, Post-Dural Puncture Headache
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov