This is interesting primarily because if it works, getting access to NAC is very easy (!), and also because it focuses on the critical neuroprotective aspect of MS intervention, whereas the majority of treatments focus specifically on immunomodulation (e.g., Tysabri). However, it is an open-label trial so placebo effect will be in full force, not to mention that the inclusion of Copaxone and a short 46-week duration will make differentiating NAC's results impossible, thereby rendering the all-too-common "Further studies are warranted" conclusion.

"A single-group, 46-week, open-label pilot study to explore the efficacy, tolerability and safety of the combination of two drugs — COPAXONE®...an approved drug for Relapsing Remitting form of Multiple Sclerosis and N-Acetylcysteine (NAC) — in 18 subjects with Relapsing Remitting Multiple Sclerosis (RRMS) is now underway...

Dr. Hyman Schipper, the lead investigating neurologist, has reason to believe that adding NAC to Copaxone may further slow disease progression and enhance the neuroprotective properties of Copaxone in MS subjects. The theory is that NAC will prevent brain iron deposition and oxidative stress.

“To date, most pre-clinical and clinical studies investigating therapies for MS have focused on the immune-mediated inflammatory stage of the disease. Far less attention has been paid to the management of the simultaneous, neurodegenerative phase of the illness, which is now believed to contribute significantly to irreversible brain tissue damage, clinical disability and brain atrophy in MS patients”, declares Dr. Hyman Schipper..."

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Potential Synergistic Effects of Copaxone and NAC to be Studied in RRMs: Combination May Enhance Neuroprotective Properties of Copaxone

MONTREAL, February 22, 2005 — A single-group, 46-week, open-label pilot study to explore the efficacy, tolerability and safety of the combination of two druugs — COPAXONE® (glatiramer acetate), an approved druug for Relapsing Remitting form of Multiple Sclerosis and N-Acetylcysteine (NAC) — in 18 subjects with Relapsing Remitting Multiple Sclerosis (RRMS) is now underway at Montreal’s Jewish General Hospital and the Neuro-Rive Sud MS Clinic.

Dr. Hyman Schipper, the lead investigating neurologist, has reason to believe that adding NAC to Copaxone may further slow disease progression and enhance the neuroprotective properties of Copaxone in MS subjects. The theory is that NAC will prevent brain iron deposition and oxidative stress.

NAC, an over-the-counter supplement, has been shown to have several anti-oxidant characteristics. Specifically, it is thought that NAC may protect cell membranes against lipid peroxidation and protein oxidation.

As these two drugs have never been administered together in this manner to MS subjects, this pilot study aims to evaluate the effect of this particular combination therapy on the disease activity. Results are to be reflected by the magnetic resonance imaging (MRI) enhancing lesions. Other MRI and clinical parameters will also be assessed, along with tolerability and safety evaluations.

Over the last decade, a considerable body of evidence in the causes of MS has implicated pathological brain iron deposition and oxidative stress. Available data strongly suggest that iron-generated free radicals and other pro-oxidant species may promote the development of potentially irreversible lesions in the central nervous system of MS patients.

“To date, most pre-clinical and clinical studies investigating therapies for MS have focused on the immune-mediated inflammatory stage of the disease. Far less attention has been paid to the management of the simultaneous, neurodegenerative phase of the illness, which is now believed to contribute significantly to irreversible brain tissue damage, clinical disability and brain atrophy in MS patients”, declares Dr. Hyman Schipper, lead investigator, expert on antioxidant therapy and neurologist at the Jewish General Hospital.

Source: http://www.pharmalive.com/News/index.cfm?articleid=214933&categoryid=10