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David

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ALS Canada is supporting a national clinical trial, which is aimed to confirm the effectiveness of lithium in slowing the progression of ALS in patients in the early stages of the disease. Patients may be included if they are within three years of their diagnosis and not already taking lithium.

The lithium clinical trial is the first joint effort by ALS clinicians in Canada who have recently formed a consortium — the Canadian ALS Clinical Trials and Research Network (CALS) — under the leadership of Dr. Lorne Zinman, medical director of the ALS Clinic at the Sunnybrook Health Sciences Centre in Toronto. The clinical trial, funded by ALS Canada, at nearly $1,000,000, is our largest research investment to date. We were able to make this investment thanks to the generous support of the Temerty Family Foundation, which has made a lead gift of $250,000, the largest solicited gift that ALS Canada has received in its 32-year history.

CALS will be joined in the clinical trial by the Northeastern ALS Consortium (NEALS), which includes internationally renowned ALS expert neurologists from Harvard University, Columbia University and a number of other prestigious university-based ALS Centres. In addition to funding by ALS Canada, the clinical trial commencing this month in Canada and the United States is being funded by The American ALS Association and the National Institutes of Health.

In Canada, the trial will be conducted at 15 ALS clinics. It is expected to be completed after two years. The trial will be a double-blind, placebo-controlled study with up to 250 patients — 125 of whom will be in Canada. The disease course and safety assessments will be measured at regular intervals over that time.

The objective of this trial is to confirm data from a small Italian clinical study that demonstrated significant positive effect in slowing the progression of ALS in patients in the early stages of the disease, through the use of lithium.

Lithium has numerous neurological effects and is a Health Canada approved drug most commonly used as a mood-stabilizing drug in treating bipolar disorder. It is a potentially toxic drug and must be taken under doctor’s supervision with frequent monitoring of blood levels. Lithium was found to protect neurons in the brain and spinal cord in animal models of neurodegenerative diseases, including Alzheimer’s and Parkinson’s.

For a list of Canadian clinics that are enrolling people with ALS, please visit http://www.als.ca/research/lithium_trial.aspx

To register in the trial, or for more information, please contact your local ALS clinic.
 
This article mentiones "small Italian clinical study that demonstrated significant positive effect in slowing the progression of ALS in patients in the early stages of the disease". I heard about this Italian study, but the "early stages" portion is something totally new to me. Does anybody have a pointer to some info about the Italian study ? Did they define what they meant by "early stages" ?
 
Well spotted. I have not noted "early stages" previously either. I do, however, know that in the UK they will be selecting patients with FVC above a certain level, no peg etc., so those may be indicators of "early stages". D
 
I am participating in a lithium study through my local ALS clinic, sponsored by ALSA in the US. In order to qualify, one must have symptoms occuring less than 3 years prior to date of entry into the study. Also no bipap.
 
The Doctor the wife goes to see in Vancouver is involved with this study. The wife and I talked about investigating more and emailed the clinic. We are scheduled back for a visit on Tuesday and we will discuss it then. I am very apprehensive at this point due to some of the side effects and don't feel comfortable with the results of the Italian study from what I have read so far. We will be asking a lot of questions and get a better understanding I am sure from the doctor herself. If she qualifies, the wife in the end will have to make that choice to participate but at least we will have a better understanding to make a decision.
 
Sukilou,

Just wondering, since I may be moving out to Portland from Montana to receive Als treatment--is that 3 years from diagnosed or from first having symptoms that qualifies you or not for being part of the clinical trial?
 
Hi Big Mike,

I've been wanting to say hello to you ever since you wrote about coming to Portland for your second opinion, so welcome to the forum! I saw Dr. Goslin at the Providence ALS Center for my second opinion, and found her to be very thorough and very caring. I feel blessed to have her as my doctor, and I attend the ALS Clinic that she is the director of.

Yes, to clarify the qualification for the lithium study, it is less than 3 yrs from first symptoms. I barely made it into the program as my symptoms started in Jan 06, and I started the study in Dec 08. There are two other studies going on at the ALS Clinic. When you go for your appt, Dr. Goslin will tell you about them, and inquire if you are interested in participating and if you qualify.

Welcome to Portland, if you decide to move here, and please let me know how your appt went.
 
Hi Sukilou! :smile:

Actuallly, I already had my appointment with Dr. Goslin last month. I found her to be very personal as well. I went out there to seek a second opinion on my als diagnosed, and she ordered a battery of tests: mri of the spine (came back normal), CT scan (normal), X-ray (normal), as well as blood and urine tests (have come in but don't know these results yet). We're still waiting on one test result to come in--a fatty acid test--perhaps this is in conjunction with my high liver enzyme readings of past several years.

I'll keep you posted of the final results as soon as I have them. If it is indeed ALS, I probably will be moving out there this year as I have a sister who lives in Portland.
 
I am on this new test the drug now as of yet. It has done nothing to help me
 
Do you mean Lithium or something else Bossman?

AL.
 
Just to follow up on this subject. The wife and I were at the GF Strong ALS Clinic on Tuesday for her 90 day checkup and asked about the Lithium trial. We were also told about another drug they are testing that is similar to Rilutek but forget the name (Maybe the wife wrote it down since I have a good memory, just short) but I digress. Even though the wifes symptoms started in Nov of 07 (less than the 3yr criteria) she was told she would not be a good candidate for the study due to LMN and UMN involvement. It would have also involved her going every 6 weeks for followups and us living on the island would be way too much and we are unable to commit to it 100%. Dr Briemberg did however just go a head and prescribed it to her. She (Dr) has a few patients taking it already with little to no side effects and has shown some positive results thus far. We have to have the usual blood work to monitor just like the Rilutek. We are going today for an x-ray on her stomach and get this blood work started. She will start the meds this week or beginning of next and will let people know what if any side effects she is experiencing and what results if any we can notice.
 
Is it Talampanel or Ceftriaxone?
 
Do you mean Lithium or something else Bossman?

AL.

yes I am on lithium started a couple of weeks ago. As of yet I find no different. So what it does. I'm not sure
 
I was diagnosed with ALS in January and will be tested in Saskatoon SK on March 18th to see if I will be accepted for the lithium trial. I assume that I have about a 25% chance of slowing this disease down a bit. It appears that no more than 50% of people on it have some luck at slowing this disease down. I have a 50% chance of getting a placebo. Thats how I came up with the 25%.
 
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