Combination Therapy in Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT00919555
Last Updated: 2012-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
28 participants
INTERVENTIONAL
2008-06-30
2012-03-31
Brief Summary
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Detailed Description
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At present, there is little to no effective therapy for ALS, nor is there a known cause. Therefore there is a tremendous unmet need for more effective therapy for this disease and that is why the physicians at PNA have been very interested in the role of developing a more active anti-excitotoxic cocktail for patients with ALS. Since recent data have suggested that inflammatory mechanisms may interact with and promote neurodegeneration (where cells in the spinal cord and brain are lost), there have been a number of anti-inflammatory treatment strategies that have been evaluated in animal models. Some studies have shown that mice that were given Pioglitazone HCL demonstrated improved muscle strength and body weight, exhibited a delayed disease onset as well as had a longer survival rate compared to non treated mice.
In addition to these studies, retinoic acids have been studied extensively in various models of the injured nervous system. These studies have shown that retinoic acids, such as Tretinoin may be neuroprotective and support axonal growth, which could in turn slow disease progression.
The purpose of this study is to determine if such a drug "cocktail" could offer the best chance of attaining a significant reduction in disease progression by utilizing currently available FDA-approved agents
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tretionoin and Pioglitazone HCL
20 patients will be randomized blindedly to Tretinoin and Pioglitazone HCL
Pioglitazone and Tretinoin
Tretinoin: 1 pill twice a day (10 mg/bid) Pioglitazone HCL: 1 pill once a day (30 mg/qd)
Tretinoin and Pioglitazone HCL
Tretinoin 10 mg 1 pill po twice a day Pioglitazone HCL 30 mg 1 pill po once a day
Sugar Pill
10 Patients will randomly receive placebo
Placebo
Placebo
Interventions
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Pioglitazone and Tretinoin
Tretinoin: 1 pill twice a day (10 mg/bid) Pioglitazone HCL: 1 pill once a day (30 mg/qd)
Tretinoin and Pioglitazone HCL
Tretinoin 10 mg 1 pill po twice a day Pioglitazone HCL 30 mg 1 pill po once a day
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Age 18 - 85 years
* Male or female
* FVC greater than or equal to 70% predicted
Exclusion Criteria
* History of liver disease
* Severe renal failure (CrCl\<30)
* History of coronary artery disease requiring placement of stents, bypass surgery or previous myocardial infarction
* EKG at baseline with evidence for previous myocardial infarction, cardiomyopathy, or arrhythmia
* History of intolerance to Riluzole, Tretinoin, or Pioglitazone HCL
* History of diabetes
* Any other comorbid condition which would make completion of trial unlikely
18 Years
85 Years
ALL
No
Sponsors
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Phoenix Neurological Associates, LTD
OTHER
Responsible Party
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Principal Investigators
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Todd D Levine, MD
Role: PRINCIPAL_INVESTIGATOR
Phoenix Neurological Associates, LTD
Locations
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Phoenix Neurological Associates, LTD
Phoenix, Arizona, United States
Countries
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Other Identifiers
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20071808
Identifier Type: -
Identifier Source: org_study_id