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
