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CompletedPhase 2

Acetazolamide Trial in Normal Pressure Hydrocephalus

Key facts

Who runs it
Uppsala University Hospital
Where
Sweden1 site in 1 countryChoose a country to see its sites
Status
Completed
Phase
Phase 2
People taking part
50 people enrolled
Started
17 Feb 2022
Ended
21 Apr 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Acetazolamide
  • Placebo
Record updated
6 May 2026

Who can take part

Age
50 years to 82 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Treatment with phenytoin, valproate, carbamazepine, lithium, oral anticoagulants, thiazide-diuretics, or acetylsalicylic acid > 100 mg/day
  • Inability to comply with the study treatment independently, and a concurrent lack of individuals to help the patient comply with the treatment during the study period
  • Other disease likely to impact the symptoms of the patient
  • Known heart failure
  • Allergy to acetazolamide, sulfonamides, or sulfonamide derivatives
  • Reduced kidney function with GFR < 50
  • Reduced liver function (increased INR or alanine transaminase concentrations in plasma elevated more than 1.5 times reference values)
  • Exclusion criteria for MRI examination
  • Participation in another medical trial
  • Wheelchair user or unable to walk without support
  • Low concentrations of electrolytes in blood plasma that, according to the investigator, prevents participation in the study
  • Angle-closure glaucoma
  • Inability to swallow capsules of the same size as the investigational medicinal products (will be tested using empty capsules when the patient is asked to participate in the study)
  • Average walking time for the three walking tests < 10.5 seconds for men and < 11.5 seconds for women
  • Average walking time for the three walking tests > 50 seconds
  • Fertile woman without highly effective contraception. A Fertile woman will be tested with pregnancy test before inclusion is possible

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • AcetazolamideExisting treatment, for comparison

    Acetazolamide (active)

  • PlaceboPlacebo, for comparison

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Double-blind Randomized Acetazolamide Trial in Normal Pressure Hydrocephalus
Publications
Record updated
6 May 2026