Dose Response Study of Nitisinone in Alkaptonuria — SONIA1

Alkaptonuria Clinical Trial

Official title:
An International, Multicentre, Randomised, Open-label, No-treatment Controlled, Parallel-group, Dose-response Study to Investigate the Effect of Once Daily Nitisinone on 24-hour Urinary Homogentisic Acid Excretion in Patients With Alkaptonuria After 4 Weeks Treatment.

Status Completed

Clinical Trial Summary

SONIA 1 is an international, multicentre, randomised, open-label, no-treatment controlled, parallel group, dose-response study to investigate the effect of once daily nitisinone on 24-hour urinary homogentisic acid excretion in patients with alkaptonuria after 4-weeks treatment. They study will identify the optimal dose to decrease urine homogentisic acid to near normal levels.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Alkaptonuria

Clinical Trial Details

NCT number	NCT01828463
Study type	Interventional
Source	University of Liverpool
Contact
Status	Completed
Phase	Phase 2
Start date	May 2013
Completion date	December 2013

View Details

See also
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Completed	`NCT04196959` - Evaluation of TYR Sphere	N/A
Recruiting	`NCT00005909` - Study of Alkaptonuria
Completed	`NCT01390077` - Nitisinone (NTBC) In Different Age Groups Of Patients With Alkaptonuria	Phase 2/Phase 3
Completed	`NCT00107783` - Long-Term Study of Nitisinone to Treat Alkaptonuria	Phase 2
Active, not recruiting	`NCT01916382` - Suitability of Nitisinone in Alkaptonuria 2	Phase 3
Not yet recruiting	`NCT06298292` - Acceptability/Tolerance of Protein Substitutes in Tablet Form for the Dietary Management of Rare Aminoacidopathies