Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis
Status:
Terminated
Trial end date:
2010-06-01
Target enrollment:
Participant gender:
Summary
Primary objective:
Efficacy of pioglitazone (45 mg/day) as add-on therapy to standard therapy with riluzole in
patients with ALS compared to placebo in terms of survival (mortality defined exclusively as
death).
This is a prospective, multicentre, randomised, stratified, parallel-group, double-blind
trial comparing placebo with 45 mg pioglitazone as add-on therapy to 100 mg riluzole in ALS
in 220 enrolled patients. For entry, the El Escorial Criteria for diagnosis will be used. The
duration of treatment will be 18 months. The primary endpoint will be subjected to a
confirmatory analyses. Secondary variables will be incidence of tracheotomy or non-invasive
ventilation, ALS Functional Rating Scale, Quality of life and safety variables.