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Treatment of Ectopic Calcification in Fahr's Disease or Syndrome

Study acronym: CALCIFADE
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Dec 2026 to Dec 2027v5
  2. Primary and study completion dates: Mar 2026 to Dec 2026
    • Study sites: 1 to 2
    v4
  3. Primary and study completion dates: Oct 2025 to Mar 2026v3
  4. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Enrollment target: 96 to 98
    • Study sites: 0 to 1
    • Primary and study completion dates: Sep 2025 to Oct 2025
    • Start date changed from estimate of Feb 2023 to Apr 3, 2023
    • Eligibility criteria expanded, about 1 word
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Fahr's disease or syndrome are neurodegenerative diseases in which patients present with bilateral vessel associated calcifications in the basal ganglia. The clinical penetration of Fahr's disease or syndrome is incomplete and heterogeneous comprising of neuropsychiatric signs, cognitive decline, movement disorders, and various other signs (migraine, speech disorders, pain, seizures). The symptoms start between 30 and 50 years and are (slowly) progressive. Symptomatic patients have an increased risk for dependence in activities of daily living and impaired quality of life. Currently, disease-modifying therapies are not available for patients with Fahr's disease or syndrome. However, in a small case series it was shown that alendronate was effective in the clinical treatment of several patients with Fahr's disease or syndrome. Now the time has come to investigate the effectiveness of treatment with bisphosphonates in patients with Fahr's disease or syndrome in a randomized controlled trial.
Trial Details
NCT Number NCT05662111
Lead Sponsor UMC Utrecht
Collaborators: Netherlands Brain Foundation
Conditions
(from sponsor)		 Fahr Disease, Fahr Syndrome, Primary Familial Brain Calcification
Related terms Fahr's disease
Enrollment 98 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov