Acetazolamide Trial in Normal Pressure Hydrocephalus (NCT04975269) | Clinical Trial Compass
CompletedPhase 2
Acetazolamide Trial in Normal Pressure Hydrocephalus
Sweden50 participantsStarted 2022-02-17
Plain-language summary
A pharmacological treatment to patients with normal pressure hydrocephalus (NPH) is missing. The aim is to investigate if acetazolamide given to patients with NPH improves gait function and study the pathophysiological mechanisms leading to reduced symptoms.
Patients will be randomized to acetazolamide or placebo and duration of treatment will be from diagnosis to the day of shunt surgery. Target dose is 500 mg/day. Study design is a double-blind randomized controlled trial and the plan is to include 42-50 patients. The study is investigator-initiated without financial sponsorship from the industry.
Who can participate
Age range50 Years – 82 Years
SexALL
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Inclusion criteria
✓. Diagnosis of idiopathic normal pressure hydrocephalus according to international guidelines
✓. Age ≥ 50 years and ≤ 82 years
✓. Cognitive function with Mini-Mental State Examination \> 20 points or cognitive domain of iNPH scale ≥ 30 points.
✓. MRI image characteristic of normal pressure hydrocephalus, defined as callosal angle \< 90 degrees and dilated lateral ventricles or pattern of disproportionately enlarged subarachnoid space hydrocephalus (DESH).
✓. Signed informed consent form
Exclusion criteria
✕. Exclusion criteria for MRI examination
✕. Participation in another medical trial
✕. Other disease likely to impact the symptoms of the patient
✕. Wheelchair user or unable to walk without support
✕. Reduced kidney function with GFR \< 50
What they're measuring
1
Proportional change in gait function
Timeframe: Change from baseline gait function immediately after intervention (at time of shunt surgery)