Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis

May 28, 2015 updated by: Albert Christian Ludolph, Prof., University of Ulm

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Department of Neurology, Humboldt University
    • Baden-Württemberg
      • Ulm, Baden-Württemberg, Germany, 89081
        • Department of Neurology, University of Ulm
    • Bayern
      • Muenchen, Bayern, Germany, D-81366
        • Department of Neurology and Center for Palliative Medicine, University of Munich
      • Regensburg, Bayern, Germany, D-93053
        • Department of Neurology, Universty of Regensburg
      • Wuerzburg, Bayern, Germany, 91054
        • Department of Neurology, University of Wuerzburg
    • Hessen
      • Wiesbaden, Hessen, Germany, D-65191
        • Department of Neurology, Deutsche Klinik für Diagnostik
    • Mecklenburg-Vorpommern
      • Rostock, Mecklenburg-Vorpommern, Germany, D-18147
        • Department of Neurology, University of Rostock
    • Niedersachsen
      • Goettingen, Niedersachsen, Germany, D-37073
        • Department of Neurology, University of Goettingen
      • Hannover, Niedersachsen, Germany, 30625
        • Department of Neurology, Medical School Hannover
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44789
        • Neurologische Universitätsklinik Bergmannsheil
      • Muenster, Nordrhein-Westfalen, Germany, D-48149
        • Department of Neurology, Universty of Muenster
    • Nordrhrein-Westfalen
      • Bonn, Nordrhrein-Westfalen, Germany, D-53105
        • Department of Neurology, Universty of Bonn
    • Sachsen
      • Dresden, Sachsen, Germany, D-01307
        • Department of Neurology, TU Dresden
    • Sachsen-Anhalt
      • Halle/Saale, Sachsen-Anhalt, Germany, 06097
        • Department of Neurology, University of Halle-Wittenberg
    • Thueringen
      • Jena, Thueringen, Germany, D-07747
        • Department of Neurology, University of Jena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria
  • disease duration more than 6 months and less than 3 years
  • best-sitting FVC between 50% and 95% of predicted normal
  • continuously treated with 100 mg riluzole daily, for at least one month
  • onset of progression weakness within 36 months prior to study
  • women of childbearing age be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test
  • capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion Criteria:

  • previous participation in another clinical study within the preceding three months
  • tracheotomy or assisted ventilation of any type during the preceding three months
  • gastrostomy
  • any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS
  • presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
  • confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT more than 1.5 upper limit of normal)
  • renal insufficiency (serum creatinine more than 2.26 mg/dl)
  • evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms
  • known hypersensitivity to any component of the study drugs
  • likely to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of an emergency
  • other antidiabetics
  • heart failure or heart failure in the patients history (NYHA I to IV)
  • history of macular oedema
  • treatment with thiazolidinediones within 3 months prior to screening
  • known or suspected history of alcohol and/or drug abuse
  • treatment with gemfibrozil within 3 months prior to screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: placebo
once daily, 18 months
Active Comparator: 1
Drug: pioglitazone
45 mg/day, 18 months
Other Names:
  • Actos

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival in patients with ALS treated with pioglitazone compared to placebo
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of tracheotomy or non-invasive ventilation
Time Frame: 18 month
18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Albert C Ludolph, MD, Prof., Department of Neurology, University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 2, 2008

First Submitted That Met QC Criteria

June 3, 2008

First Posted (Estimate)

June 4, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 28, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GERP ALS
  • EUDRACT NUMBER 2006-005410-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Clinical Trials on pioglitazone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe