Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT00690118
Status:
TERMINATED
Last Update Posted:
2015-05-29
First Post:
2008-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}}, 'statusModule': {'whyStopped': 'The interim analysis showed no tendency in favour of the verum group. Therefore it was decided to stop the study prematurely.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-28', 'studyFirstSubmitDate': '2008-06-02', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival in patients with ALS treated with pioglitazone compared to placebo', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of tracheotomy or non-invasive ventilation', 'timeFrame': '18 month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['amyotrophic lateral sclerosis', 'survival time', 'ALS functioning Rating Scale', 'quality of life', 'non-invasive ventilation', 'clinical tolerability', 'survival'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'referencesModule': {'references': [{'pmid': '16120782', 'type': 'BACKGROUND', 'citation': 'Schutz B, Reimann J, Dumitrescu-Ozimek L, Kappes-Horn K, Landreth GE, Schurmann B, Zimmer A, Heneka MT. The oral antidiabetic pioglitazone protects from neurodegeneration and amyotrophic lateral sclerosis-like symptoms in superoxide dismutase-G93A transgenic mice. J Neurosci. 2005 Aug 24;25(34):7805-12. doi: 10.1523/JNEUROSCI.2038-05.2005.'}, {'pmid': '15649489', 'type': 'BACKGROUND', 'citation': 'Kiaei M, Kipiani K, Chen J, Calingasan NY, Beal MF. Peroxisome proliferator-activated receptor-gamma agonist extends survival in transgenic mouse model of amyotrophic lateral sclerosis. Exp Neurol. 2005 Feb;191(2):331-6. doi: 10.1016/j.expneurol.2004.10.007.'}, {'pmid': '22715372', 'type': 'DERIVED', 'citation': 'Dupuis L, Dengler R, Heneka MT, Meyer T, Zierz S, Kassubek J, Fischer W, Steiner F, Lindauer E, Otto M, Dreyhaupt J, Grehl T, Hermann A, Winkler AS, Bogdahn U, Benecke R, Schrank B, Wessig C, Grosskreutz J, Ludolph AC; GERP ALS Study Group. A randomized, double blind, placebo-controlled trial of pioglitazone in combination with riluzole in amyotrophic lateral sclerosis. PLoS One. 2012;7(6):e37885. doi: 10.1371/journal.pone.0037885. Epub 2012 Jun 8.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\nEfficacy 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).\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* possible, probable (clinically or laboratory) or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria\n* disease duration more than 6 months and less than 3 years\n* best-sitting FVC between 50% and 95% of predicted normal\n* continuously treated with 100 mg riluzole daily, for at least one month\n* onset of progression weakness within 36 months prior to study\n* 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\n* capable of thoroughly understanding all information given and giving full informed consent according to GCP\n\nExclusion Criteria:\n\n* previous participation in another clinical study within the preceding three months\n* tracheotomy or assisted ventilation of any type during the preceding three months\n* gastrostomy\n* any medical condition known to have an association with motor neuron dysfunction which might confound or obscure the diagnosis of ALS\n* presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment\n* confirmed hepatic insufficiency or abnormal liver function (ASAT and/or ALAT more than 1.5 upper limit of normal)\n* renal insufficiency (serum creatinine more than 2.26 mg/dl)\n* evidence of major psychiatric disorder or clinically evident dementia precluding evaluation of symptoms\n* known hypersensitivity to any component of the study drugs\n* 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\n* other antidiabetics\n* heart failure or heart failure in the patients history (NYHA I to IV)\n* history of macular oedema\n* treatment with thiazolidinediones within 3 months prior to screening\n* known or suspected history of alcohol and/or drug abuse\n* treatment with gemfibrozil within 3 months prior to screening'}, 'identificationModule': {'nctId': 'NCT00690118', 'briefTitle': 'Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Efficacy, Safety and Tolerability Study of 45 mg Pioglitazone in Patients With Amyotrophic Lateral Sclerosis (ALS) Receiving Standard Therapy (Riluzole)', 'orgStudyIdInfo': {'id': 'GERP ALS'}, 'secondaryIdInfos': [{'id': 'EUDRACT NUMBER 2006-005410-13'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: pioglitazone']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos'], 'description': '45 mg/day, 18 months', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'once daily, 18 months', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Department of Neurology, University of Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': 'D-81366', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Neurology and Center for Palliative Medicine, University of Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': 'D-93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Neurology, Universty of Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '91054', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of Neurology, University of Wuerzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': 'D-65191', 'city': 'Wiesbaden', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Department of Neurology, Deutsche Klinik für Diagnostik', 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}, {'zip': 'D-37073', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Department of Neurology, University of Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30625', 'city': 'Hanover', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'Department of Neurology, Medical School Hannover', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'D-18147', 'city': 'Rostock', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Department of Neurology, University of Rostock', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}, {'zip': 'D-53105', 'city': 'Bonn', 'state': 'Nordrhrein-Westfalen', 'country': 'Germany', 'facility': 'Department of Neurology, Universty of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '44789', 'city': 'Bochum', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Neurologische Universitätsklinik Bergmannsheil', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': 'D-48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Neurology, Universty of Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': 'D-01307', 'city': 'Dresden', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Neurology, TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '06097', 'city': 'Halle', 'state': 'Saxony-Anhalt', 'country': 'Germany', 'facility': 'Department of Neurology, University of Halle-Wittenberg', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': 'D-07747', 'city': 'Jena', 'state': 'Thuringia', 'country': 'Germany', 'facility': 'Department of Neurology, University of Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Department of Neurology, Humboldt University', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Albert C Ludolph, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Ulm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Ulm', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinating Investigator', 'investigatorFullName': 'Albert Christian Ludolph, Prof.', 'investigatorAffiliation': 'University of Ulm'}}}}