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IRB Number : 1011-03

Trial Status : Open for Enrollment

Why is this study being done?
The purpose of this multicenter trial is to test the safety, tolerability and effectiveness of minocycline compared to placebo (inactive substance) in patients with ALS. Minocycline is an antibiotic of the tetracycline group that is currently approved by the US Food and Drug Administration for treatment of bacterial infections. The drug inhibits the activity of enzymes that are involved in cell death pathways. Minocycline has been shown to slow ALS deterioration in animal studies.

Who is Eligible to Participate in the Study?
To be eligible for enrollment in this study the patient must meet the following criteria:

Inclusion Criteria

Clinical diagnosis of probable or definite ALS

Onset of weakness within 3 years

FVC (Forced vital capacity) greater or equal of 75 % predicted

21 to 85 years of age

Ability to comply with study requirements

Exclusion Criteria

Familial ALS (parent, sibling or child with ALS)

Forced vital capacity < 75% predicted

Need for tracheostomy ventilation

Clinically significant history of unstable medical illness

Significant liver or kidney disease

Allergy to tetracycline antibiotics

Pregnancy or breastfeeding

Use of any investigational drug within 30 days (Creatine, Celebrex, Coenzyme Q10, Topamax, and Minocycline)

What is Involved With this Study?
Mayo Clinic in Scottsdale is one of 25 ALS centers in the United States participating in this National Institute of Health funded study. The primary outcome measure is change in function as detected by the ALS Functional Rating Scale (a questionnaire designed to assess functional ability) over time. The secondary outcome measures are changes in manual muscle strength, forced vital capacity (a respiratory test), quality of life and survival.

Each participant will undergo monthly outpatient evaluations and analysis of laboratory and adverse events. After a four-month observational period the participant, will be randomly chosen to receive drug or placebo for 9 months.

Who can I Contact for Additional Information on this Trial?
For more information call Joyce Wisbey, R.N. at (480) 301-9392 at Mayo Clinic Arizona or Anne Evans (904) 953-7720 at Mayo Clinic Jacksonville.

What is/are the Locations of this Clinical Trial?
Jacksonville, FL
Scottsdale and Phoenix, AZ

In my experience, I first went to see a Neuro, before an LLMD, as i had bells palsy, slurred speech, respiratory problems, muscle cramping & twitching, muscle weakness, and a foot-drop.

The Neuro didn't acknowledge Lyme Disease or associated coinfections at all. The LLMD, did acknowledge ALL of my symptoms, and my past history of having & being treated for Lyme Disease 6 yrs. previous, and of course the positive test results, and therefore treated me accordingly.

With Bicillin LA, IM, i had dramatic improvement; my speech improved as well as my balance; when i was treated for coinfections, Babesia & Erlichiosis, i got my breath back and my energy.

Bicillin was the best drug for me, as was the treatment of the coinfections.

I only noticed a decline after my LLMD recommended I get flu shot, and then he increased my dosage of Rocephin & Augm. at the same time.

I have heard there is mercury in those flu shots, and I didn't experience improvements with Rocephin & Augm combo. I don't know why in the world this LLMD would recommend I get a flu shot at that time, when there was active infection and loads of abx in me!

I'm in the process now of finding a new LLMD, as well as heavy metal testing.

I'm very hopeful once I have a new LLMD, the right abx combo that I have great results with, coinfections & heavy metals addressed properly, that I will continue to improve.

I began my Neuro visit telling him i had lyme 5 yrs ago, and that now it's back, but worse. This Neuro never even tested me for lyme or coinfections, actually said "we don't do that here", but he did send me back out for an AIDS test, "so as to rule everything out & because there was 1 case in NY where someone showed the same symptoms as me, and was given an aids cocktail, which led to recovery". Go figure...

So my question is - How many of these ALS cases are untreated, advanced stages of Lyme Disease & coinfections to begin with?

I always knew Lyme was my demon. To me, A.L.S stands for Also Lyme Symptoms. Why is it now that all these studies are using abx treatment for ALS & MS, even Hopkins? Sure, they won't dare say it's to treat bacteria running rampant in your body, rather, they will claim they use abx to cause a "protein reaction". Oh, okay....

If they find that this spirochete can in fact cause ALS or MS symptoms, can you imagine how much grant and research money is at stake? My god, they have been receiving millions of dollars for so many years, yet they have no idea of the cause or any drugs to treat it.

Oh, i forgot they have one drug Rilutek, it costs about $1000/month and doesn't do anything. In fact, if you have the BB bacteria, it can actually make it progress faster. In my experience, i was on it 15 days, and it almost killed me by making my breathing and swallowing worse.

History has shown what the syphilis spirochete can do to the nervous system, brain, and the whole body for that matter. So why is it that they wont look closer at bb spirochete that is so very similar?

In the 80's so many people would come out of school and study aids, not that they necessarily wanted to, but they knew if they wanted research money that's where all the money was going.

We need more grant money for BB and tick born coinfections, & better testing protocol in place, then maybe we have a chance.

They will realize some day what a serious problem this is. Like i said above, i was treated years before and then relapsed, perhaps due to repeated infections.