Status:
TERMINATED
Study of Pioglitazone in Patients With Amyotrophic Lateral Sclerosis
Lead Sponsor:
University of Ulm
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 exclusivel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00690118
Start Date
May 1 2008
End Date
June 1 2010
Last Update
May 29 2015
Active Locations (15)
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1
Department of Neurology, University of Ulm
Ulm, Baden-Wurttemberg, Germany, 89081
2
Department of Neurology and Center for Palliative Medicine, University of Munich
Munich, Bavaria, Germany, D-81366
3
Department of Neurology, Universty of Regensburg
Regensburg, Bavaria, Germany, D-93053
4
Department of Neurology, University of Wuerzburg
Würzburg, Bavaria, Germany, 91054