NL-OMON53560
Recruiting
Phase 2
A randomized, placebo-controlled, double blind trial to study the effects of Etidronate on ectopic CALCIfication in FAhr*s Disease or syndrome. - CALCIFADE trial
niversitair Medisch Centrum Utrecht0 sites98 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Fahr's disease
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 98
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age of 18 years or over.
- •2\. Clinical diagnosis of Fahr\*s disease or syndrome. No international accepted
- •diagnostic criteria for Fahr\*s disease or syndrome exist yet. It is diagnosed
- •mostly based on the clinical presentation. For the present study the following
- •criteria are used:
- •a. Clinical symptoms consistent with a clinical diagnosis of Fahr\*s disease or
- •b. Bilateral calcifications of the basal ganglia as seen on the CT scan of the
- •head. To rule out basal ganglia calcifications due to aging, a CT based
- •calcification score will be used as proposed by Nicolas et al. Calcification is
- •graded from 0 (no calcification) to 5 (serious and confluent) in specific
Exclusion Criteria
- •1\. Unable or unwilling to sign an informed consent.
- •2\. Severe renal impairment (estimated creatinine clearance/eGFR of \<30
- •ml/min/1\.73m2 calculated using CKD\-EPI equation).
- •3\. Contraindication to receiving oral medication.
- •4\. Known abnormality of the esophagus that would interfere with the passage of
- •5\. Known sensitivity to etidronate.
- •6\. Pregnancy, women with an active pregnancy wish \<1 year, or women who are
- •breastfeeding at the time of inclusion.
- •7\. Any other medical or social condition that, in the opinion of the Principal
- •Investigator, might put the subject at risk of harm during the study or might
Outcomes
Primary Outcomes
Not specified
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