Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
Phase IIA Trial: Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral Sclerosis
The purpose of the study is to determine the safety and the efficacy of Tretinoin and Pioglitazone HCL in patients with ALS who are currently on Riluzole.
Physicians at Phoenix Neurological Associates (PNA) are looking for individuals diagnosed
with ALS to participate in a double-blind, placebo controlled study of Tretinoin and
Pioglitazone HCL, used in combination with Riluzole, for treating ALS. This investigator
initiated trial conducted by Dr. Todd Levine and Dr. David Saperstein will help determine
whether Tretinoin and Pioglitazone HCL, in combination, can slow the progression of ALS.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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