FW: New Clinical Trial Opens

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Incase anyone is interested. Shame they still refuse to trial LDN.Bev

bevkean777@...From: jmcconkey@...Subject: New Clinical Trial OpensDate: Thu, 10 Mar 2011 14:04:04 -0600 If you're having trouble viewing this email, you may see it online.

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Summary: Investigators worldwide are recruiting 1350 people with MS to study the safety and effectiveness of glatiramer acetate (Teva Pharmaceutical Industries, Ltd.). The current approved dose for glatiramer acetate is 20 mg per day delivered subcutaneously (under the skin), and this study is investigating the effectiveness of a higher dose, 40 mg, given less frequently (three times a week). The one-year study is funded by Teva Pharmaceutical Industries, Ltd., and is also called the GALA study.

Rationale: Glatiramer acetate is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Glatiramer acetate is approved by the U.S. Food and Drug Administration to reduce the frequency of relapses in patients with relapsing-remitting MS and for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with MS.

Eligibility and details: Participants should be 18 to 55 years of age with a confirmed diagnosis of relapsing-remitting MS. Participants must be in a relapse-free, stable neurological condition for a minimum of 30 days, but have experienced at least one documented relapse in the past 12 months, two documented relapses in the past 24 months, or one documented relapse between 12 and 24 months with disease activity on MRI. Further details on enrollment criteria are available from the contact below.Participants will be randomly assigned to receive either glatiramer acetate 40 mg or inactive placebo three times a week subcutaneously for 12 months. The primary endpoint being measured is the effectiveness in reducing the total number of relapses, and secondary endpoints being measured are new disease activity on MRI, cumulative disease activity on MRI, and brain tissue volume loss. Other endpoints under study include quality of life.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email UStevatrials@....

Sites are going to be recruiting in the following U.S. cities:Akron, OH Aurora, CO Boulder, COCentennial, COColumbus, OHDayton, OHDetroit, MIFort , COFullerton, CAGilbert, AZKirkland, WALa Jolla, CALenexa, KSLexington, KYLubbock, TXMiami, FLNaples, FLNashville, TNNorthbrook, ILOklahoma City, OKPhoenix, AZPompano Beach, FLPonte Verde, FLRichmond, VARoanoke, VARound Rock, TXSalt Lake City, UTSan , TX Sarasota, FL Shreveport, LATampa, FLUniontown, OHVero Beach, FLVienna, VA

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Rocky Mountain Multiple Sclerosis Center 8845 Wagner St. | Westminster, CO 80031

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Should some drug company trial LDN, and they will not unless they get exclusive rights, I will not be able to afford it. There are lots of examples of drugs that were cheap until the drug company got exclusive rights to them and then they increased the price 100's perhaps 1000's %.SterlingFrom: Bev Kean <bevkean777@...>Subject: [low dose naltrexone] FW: New Clinical Trial Openslow dose naltrexone Date: Thursday, March 10, 2011, 5:51 PM

Incase anyone is interested. Shame they still refuse to trial LDN.Bev

bevkean777@...From: jmcconkey@...Subject: New Clinical Trial OpensDate: Thu, 10 Mar 2011 14:04:04 -0600 If you're having trouble viewing this email, you may see it online.

Share This:

Summary: Investigators worldwide are recruiting 1350 people with MS to study the safety and effectiveness of glatiramer acetate (Teva Pharmaceutical Industries, Ltd.). The current approved dose for glatiramer acetate is 20 mg per day delivered subcutaneously (under the skin), and this study is investigating the effectiveness of a higher dose, 40 mg, given less frequently (three times a week). The one-year study is funded by Teva Pharmaceutical Industries, Ltd., and is also called the GALA study.

Rationale: Glatiramer acetate is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This therapy seems to block myelin-damaging T-cells through a mechanism that is not completely understood. Glatiramer acetate is approved by the U.S. Food and Drug Administration to reduce the frequency of relapses in patients with relapsing-remitting MS and for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with MS.

Eligibility and details: Participants should be 18 to 55 years of age with a confirmed diagnosis of relapsing-remitting MS. Participants must be in a relapse-free, stable neurological condition for a minimum of 30 days, but have experienced at least one documented relapse in the past 12 months, two documented relapses in the past 24 months, or one documented relapse between 12 and 24 months with disease activity on MRI. Further details on enrollment criteria are available from the contact below.Participants will be randomly assigned to receive either glatiramer acetate 40 mg or inactive placebo three times a week subcutaneously for 12 months. The primary endpoint being measured is the effectiveness in reducing the total number of relapses, and secondary endpoints being measured are new disease activity on MRI, cumulative disease activity on MRI, and brain tissue volume loss. Other endpoints under study include quality of

life.

Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please email UStevatrials@....

Sites are going to be recruiting in the following U.S. cities:Akron, OH Aurora, CO Boulder, COCentennial, COColumbus, OHDayton, OHDetroit, MIFort , COFullerton, CAGilbert, AZKirkland, WALa Jolla, CALenexa, KSLexington, KYLubbock, TXMiami, FLNaples, FLNashville, TNNorthbrook, ILOklahoma City, OKPhoenix, AZPompano Beach, FLPonte Verde, FLRichmond, VARoanoke, VARound Rock, TXSalt Lake City, UTSan , TX Sarasota, FL Shreveport, LATampa, FLUniontown, OHVero Beach, FLVienna, VA

Click to download this as a PDF

Rocky Mountain Multiple Sclerosis Center 8845 Wagner St. | Westminster, CO 80031

This email was sent to bevkean777@.... To ensure that you continue receiving our emails, please add us to your address book or safe list. manage your preferences | opt out using TrueRemove®.Got this as a forward? Sign up to receive our

future emails.