Tretinoin and Pioglitazone HCL Combination Therapy in Amyotrophic Lateral Sclerosis

Trial Status
Open for Enrollment

What is the Purpose of this Study?
The devastating nature of this disease suggests that a drug cocktail may offer the best chance of attaining a significant reduction in disease progression. Therefore a trial of Riluzole, in combination with Pioglitazone HCL, a FDA-approved PPAR gamma agent for type II diabetes, and Tretinoin, a FDA-approved retinoid for acute procrymyclonic leukemia is proposed.

Who is Eligible to Participate?
Patients diagnosed with Amyotrophic Lateral Sclerosis who are currently being treated with Riluzole, with no history of liver disease, heart disease or diabetes. Patients must also meet all other inclusion and exclusion criteria explained in further detail by the study coordinator

What is involved in this Study?
This is a double-blinded, placebo controlled study. 2/3 of patients will receive Tretinin and Pioglitazone Hcl in conjunction with their Riluzole, and 1/3 will receive placebo in conjunction with their Riluzole. Your first visit is to determine if you are eligible to participate in the study. This visit consists of a Forced Vital Capacity test to determine your lung functioning, blood tests; an EKG, a questionnaire as well as a lumbar puncture will be performed to determine your baseline levels. You will receive drug approximately 4 weeks later, and every 4 weeks you will return to clinic for drug dispensing, blood tests and neuro exams.

How long is the Study?
It is approximately 32 weeks long. You will be on study drug for 24 weeks.

For More Information Contact: Nicole C. Hank, MHSM, study coordinator, at 602-258-3354 ext 137 or nhank@pnal.net or call the Main line at 602-258-3354