NCT00690118

Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: University of Ulm · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	pioglitazone	45 mg/day, 18 months
DRUG	placebo	once daily, 18 months

Timeline

• Start date: 2008-05-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-06-04
• Last updated: 2015-05-29

Locations

15 sites across 1 country: Germany