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A randomized, placebo-controlled, double blind trial to study the effects of Etidronate on ectopic CALCIfication in FAhr’s Disease or syndrome: CALCIFADE trial

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-512300-19-00
Acronym
22U-0320
Enrollment
98
Registered
2024-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-01-23

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

Conditions

Fahr's disease, Fahr's syndrome

Brief summary

Change in cognitive functioning of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline.

Detailed description

Change in mobility of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in psychiatric symptoms of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in daily functioning of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in quality of life of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in calcification in the brain of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline.

Interventions

DRUGETIDRONATE DISODIUM ORAL CAPSULES 400 MG PLACEBO

Sponsors

Universitair Medisch Centrum Utrecht
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in cognitive functioning of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline.

Secondary

MeasureTime frame
Change in mobility of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in psychiatric symptoms of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in daily functioning of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in quality of life of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline., Change in calcification in the brain of patients with Fahr’s disease or syndrome treated with etidronate or placebo between baseline and 12 months after baseline.

Countries

Netherlands

Outcome results

None listed

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