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| Sponsor: | University of Ulm |
|---|---|
| Information provided by: | University of Ulm |
| ClinicalTrials.gov Identifier: | NCT00690118 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Amyotrophic Lateral Sclerosis |
Drug: pioglitazone Drug: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole) |
| Enrollment: | 219 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: pioglitazone
45 mg/day, 18 months
Other Name: Actos
|
| Placebo Comparator: 2 |
Drug: placebo
once daily, 18 months
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Department of Neurology, University of Ulm | |
| Ulm, Baden-Württemberg, Germany, 89081 | |
| Department of Neurology and Center for Palliative Medicine, University of Munich | |
| Muenchen, Bayern, Germany, D-81366 | |
| Department of Neurology, Universty of Regensburg | |
| Regensburg, Bayern, Germany, D-93053 | |
| Department of Neurology, University of Wuerzburg | |
| Wuerzburg, Bayern, Germany, 91054 | |
| Department of Neurology, Deutsche Klinik für Diagnostik | |
| Wiesbaden, Hessen, Germany, D-65191 | |
| Department of Neurology, University of Rostock | |
| Rostock, Mecklenburg-Vorpommern, Germany, D-18147 | |
| Department of Neurology, University of Goettingen | |
| Goettingen, Niedersachsen, Germany, D-37073 | |
| Department of Neurology, Medical School Hannover | |
| Hannover, Niedersachsen, Germany, 30625 | |
| Neurologische Universitätsklinik Bergmannsheil | |
| Bochum, Nordrhein-Westfalen, Germany, 44789 | |
| Department of Neurology, Universty of Muenster | |
| Muenster, Nordrhein-Westfalen, Germany, D-48149 | |
| Department of Neurology, Universty of Bonn | |
| Bonn, Nordrhrein-Westfalen, Germany, D-53105 | |
| Department of Neurology, University of Halle-Wittenberg | |
| Halle/Saale, Sachsen-Anhalt, Germany, 06097 | |
| Department of Neurology, TU Dresden | |
| Dresden, Sachsen, Germany, D-01307 | |
| Department of Neurology, University of Jena | |
| Jena, Thueringen, Germany, D-07747 | |
| Department of Neurology, Humboldt University | |
| Berlin, Germany, 13353 | |
| Principal Investigator: | Albert C Ludolph, MD, Prof. | Department of Neurology, University of Ulm |
More Information
| Responsible Party: | Albert C Ludolph, Prof. MD, Department of Neurology, University of Ulm, Oberer Eselsberg 45, D-89081 Ulm |
| ClinicalTrials.gov Identifier: | NCT00690118 History of Changes |
| Other Study ID Numbers: | GERP ALS, EUDRACT NUMBER 2006-005410-13 |
| Study First Received: | June 2, 2008 |
| Last Updated: | June 1, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
amyotrophic lateral sclerosis survival time ALS functioning Rating Scale quality of life |
non-invasive ventilation clinical tolerability survival |
|
Amyotrophic Lateral Sclerosis Sclerosis Motor Neuron Disease Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases TDP-43 Proteinopathies |
Neuromuscular Diseases Proteostasis Deficiencies Metabolic Diseases Pathologic Processes Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |