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Double-blind randomized acetazolamide trial in normal pressure hydrocephalus (DRAIN)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514828-16-00
Acronym
NPH-01
Enrollment
56
Registered
2024-10-25
Start date
2025-09-25
Completion date
Unknown
Last updated
2024-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal pressure hydrocephalus

Brief summary

The relative change in gait between walking trials is the primary outcome measure. Walking is examined as the sum of time and steps required to walk a distance of 10 meters, timed up-and-go (TUG), and walking backwards for 3 meters

Detailed description

Quality of life assessed by the EQ-5D-5L self-completion questionnaire and questionnaires 1-2 that estimate the patient's own experience of symptoms and side effects, respectively, The volume of periventricular white matter calculated by volumetric analysis of brain MRI, The total symptomatic change in motor skills, cognition, and continence, assessed using the Swedish iNPH scale, Blood and cerebrospinal fluid biomarkers (neurofilament light chain protein (NFL), amyloid-beta-42, Tau, and glial fibrillary acidic protein (GFAp))

Interventions

DRUGThe Placebo is a Size 00el capsule shell with a Microcrystalline Cellulose fill. Please see Simplified IMPD for detailed information.
DRUGACETAZOLAMIDE

Sponsors

Region Uppsala
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The relative change in gait between walking trials is the primary outcome measure. Walking is examined as the sum of time and steps required to walk a distance of 10 meters, timed up-and-go (TUG), and walking backwards for 3 meters

Secondary

MeasureTime frame
Quality of life assessed by the EQ-5D-5L self-completion questionnaire and questionnaires 1-2 that estimate the patient's own experience of symptoms and side effects, respectively, The volume of periventricular white matter calculated by volumetric analysis of brain MRI, The total symptomatic change in motor skills, cognition, and continence, assessed using the Swedish iNPH scale, Blood and cerebrospinal fluid biomarkers (neurofilament light chain protein (NFL), amyloid-beta-42, Tau, and glial fibrillary acidic protein (GFAp))

Countries

Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026