Trial intelligence / Profile preview

Diet and Medication in Cerebrotendinous Xanthomatosis

NCT00004346Phase 2

Key facts

Status
Unknown
Start
Jan 1996
Countries
1
Sponsor
National Center for Research Resources
Modality
Recombinant Proteins and Enzymes, Small Molecules
Conditions
cerebrotendinous xanthomatosis (CTX)
01

Overview

Phase 2, open-label trial of lovastatin and chenodeoxycholic acid in cerebrotendinous xanthomatosis (CTX) (2 arms), sponsored by National Center for Research Resources. Primary endpoints: Biosynthesis of cholesterol at 10 weeks, Biosynthesis of cholestanol at 10 weeks and 2 more. Status: unknown.

02

Design

2 arms
Study design
Non-randomizedOpen-label
  • Lovastatin Final Arm

    Receives Lovastatin in the final phase

  • CDCA Final Arm

    Receives Chenodeoxycholic acid in the final phase

03

Who it enrols

Patients with Cerebrotendinous xanthomatosis.

04

Endpoints

Primary

  • Biosynthesis of cholesterol

  • Biosynthesis of cholestanol

  • Turnover of individual sterols

  • Turnover of bile acids

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