Treatment of normal pressure hydrocephalus with acetazolamid

Phase 1

• Conditions: ormal pressure hydrocephalus; MedDRA version: 20.0Level: LLTClassification code 10020510Term: Hydrocephalus acquiredSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-004132-22-SE
• Lead Sponsor: ppsala University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-30
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1. Diagnosis of idiopathic normal pressure hydrocephalus according to international guidelines
2. Age =50 years and = 82 years
3. Cognitive function with Mini-Mental State Examination > 20 points or cognitive domain of the iNPH scale =30 points
4. MRI image for iNPH defined as callosal angle <95 degrees and dilated lateral ventricles or image as in disproportionately subarachnoid space hydrocephalus (DESH)
5. Signed informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion Criteria

1. Exclusion criteria for MRI examination
2. Participation in another medical trial
3. Other disease likely to impact the symptoms of the patient
4. Wheelchair bound or in need of support when walking
5. Reduced kidney function with creatinine GFR < 50
6. Reduced liver function: Prothrombin complex > 1.2 or increased alanine transaminase concentrations in plasma 1.5 times above the upper reference value (women > 1.125 mkat/L; men > 1.65 mkat/L).
7. Known heart failure
8. Low concentrations of electrolytes in blood plasma, or other illness or treatment that may cause significant lowering of electrolyte concentrations according to the investigator
9. Angle-closure glaucoma
10. Allergy to acetazolamide, sulfonamides, or sulfonamide derivatives
11. Treatment with phenytoin, valproate, carbamazepine, lithium, thiazide-diuretics > 25mg/day, acetylsalicylic acid > 100 mg/day, daily use of NSAID or furosemide > 20 mg/day
12. 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)
13. Average walking time for the three walking tests <10.5 seconds for men and <11.5 seconds for women
14. Average walking time for the three walking tests > 50 seconds
15. 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
16. Females who are not infertile or females of childbearing potential who do not use highly effective birth control. For females of childbearing potential a negative pregnancy test will be documented before inclusion

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified