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Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

NCT00690118 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 219

Last updated 2015-05-29

No results posted yet for this study

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

Interventions

DRUG

pioglitazone

45 mg/day, 18 months

DRUG

placebo

once daily, 18 months

Sponsors & Collaborators

  • University of Ulm

    lead OTHER

Principal Investigators

  • Albert C Ludolph, MD, Prof. · Department of Neurology, University of Ulm

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00690118 on ClinicalTrials.gov