Trial intelligence / Profile preview

Long-term Deferiprone in Friedreich's Ataxia

NCT00897221Phase 2

Key facts

Status: Completed
Start: Jun 2009
Primary completion: Mar 2011
Countries: 4
Sponsor: ApoPharma Inc.
Modality: Small Molecules

Drugs: deferiprone
Conditions: Friedreich's ataxia (FA)

Overview

Phase 2, open-label trial of deferiprone in Friedreich's ataxia (FA) (2 arms), sponsored by ApoPharma Inc. Primary endpoint: Adverse Events at 52 weeks. Started Jun 2009; status: completed.

Design

2 arms

Study design: Non-randomizedOpen-label

Dose 1
Deferiprone 20 mg/kg/day
Dose 2
Deferiprone 40 mg/kg/day

Who it enrols

Patients with Friedreich's Ataxia who completed the LA29-0207 study, with acceptable ferritin/hemoglobin levels and no history of neutropenia.

Endpoints

Primary

Adverse Events52 weeks

Secondary

9-Hole Peg Test52 weeks
Timed 25-Foot Walk52 weeks
Low-Contrast Letter Acuity52 weeks
International Cooperative Ataxia Rating Scale52 weeks
Friedreich's Ataxia Rating Scale52 weeks

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