Zinc Therapy in ALS
Trial Status
Open for Enrollment
What is the Purpose of this Study?
The primary study objectives is to
determine if treatment with AEN-100 (a zinc supplement) at 225mg/day
or 150mg/day is efficacious compared to placebo in slowing the rate of
progression of ALS as measured by change in ALSFRS-R over the 9 months
of therapy. Secondary measures of efficacy will include the in Forced
Vital Capacity (FVC). If an interim analysis after six months of therapy
or data analysis at the end of the trial determines that treatment with
AEN-100 is more efficacious and safe compared to placebo then the study
will recruit additional patients, as well as roll-over patients who still
meet eligibility into a single dose vs. placebo phase III study
Who is Eligible to Participate?
Patients diagnosed with Amyotrophic
Lateral Sclerosis who are currently being treated with or without Riluzole,
with no history of liver disease, heart disease, hof intolerance to zinc
or copper. Must have a FVC > than 70%. Patients must also meet all
other inclusion and exclusion criteria explained in further detail by
study coordinator
What is involved in this Study?
Eligible patients will be randomized
(2:2:1) to matching placebos (N), 225mg/d (N%) or 150 mg/d (N%) of AEN-100
and 1 mg of copper. 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, a questionnaire
as well as a physical and neurological exam. You will receive drug approximately
2 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 36 weeks long.
For More Information Contact: Nicole
C. Hank, MHSM, study coordinator, at 602-258-2432 or nhank@pnal.net or call the Main line at 602-258-3354
