drugset / Trial / NCT05707442

Stent Implantation Versus Medical Therapy for Idiopathic IntracraniaL Hypertension (SIMPLE)

NCT05707442

Phase 3 Recruiting 74 enrolled Beijing Tiantan Hospital
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to assess the efficacy of stent implantation versus medical therapy on idiopathic intracranial hypertension with venous sinus stenosis.

Timeline

Start
2023-02-16
Primary completion
2027-01
Completion
2027-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetazolamide Small molecule 4 g
Comparator Mannitol Diagnostic / imaging agent 0.25 g/kg
Comparator Mannitol Diagnostic / imaging agent 1 g/kg