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Tolerability and Safety of Combined Glatiramer Acetate and N-Acetylcysteine in Relapsing-Remitting Multiple Sclerosis

Schipper, Hyman M. MD, PhD, FRCP(C)*†‡; Arnold, Douglas MD; Grand'Maison, Francois MD, FRCP(C); Melmed, Calvin MD, FRCP(C)*; Moore, Fraser MD, FRCP(C)*; Levental, Mark MD, FRCP(C); Su, Haixiang MD, PhD; Constantin, Michel MSc#; Stril, Jean-Louis MD#; Godin, Jean MD, MBA#

doi: 10.1097/WNF.0000000000000090
Original Articles

Introduction Multiple sclerosis (MS) is an autoimmune disorder of the central nervous system where inflammation and neurodegeneration play key roles. Mounting evidence implicates oxidative stress in the development of irreversible neuronal and glial injury in this condition. N-acetylcysteine (NAC) is a sulfhydryl amino acid derivative with antioxidant and antiapoptotic properties. Administration of NAC to mice attenuated the induction of or improved experimental autoimmune encephalomyelitis (an MS model).

Methods We performed an open-label study to explore the tolerability and safety of the combination of glatiramer acetate (GA) and NAC in patients with relapsing-remitting multiple sclerosis at the outpatient MS clinics of the Jewish General Hospital and Hôpital Charles Lemoyne, Montreal, Canada. Seven patients with relapsing-remitting multiple sclerosis with at least one T1 gadolinium-enhancing lesion on screening magnetic resonance imaging were recruited. Treatment consisted of a 10-week run-in period followed by 36-week treatment with a combination of GA 20 mg subcutaneously once daily plus NAC 2.5 g orally twice daily. Outcome measures included safety and tolerability, redox biochemistry, and magnetic resonance imaging effect.

Results Treatment with the combination of GA and NAC was safe and well tolerated.

Conclusions In light of the favorable safety profile, an efficacy-demonstrating study may be considered.

Departments of *Neurology and Neurosurgery, and †Medicine (Geriatrics), McGill University; ‡Lady Davis Institute for Medical Research, Jewish GeneralHospital; §NeuroRx Research; ∥Hôpital Charles Lemoyne; ¶Department of Radiology, Jewish General Hospital; and #Teva Neuroscience Canada, Montreal,Quebec, Canada.

Address correspondence and reprint requests to Hyman M. Schipper, MD, PhD, FRCP(C), Lady Davis Institute for Medical Research, Jewish General Hospital, 3755 Cote Ste. Catherine Rd, Montreal, Quebec, Canada H3T 1E2; E-mail: hyman.schipper@mcgill.ca.

Conflicts of Interest and Source of Funding: H.M.S. has served as consultant to Caprion Pharmaceuticals, Molecular Biometrics Inc, Osta Biotechnologies, Teva Neurosciences, Immunotec, and Apopharma. C.M. has been an investigator in clinical trials conducted by Eisai and a consultant to Taro Pharmaceuticals. D.A. and F.G'M. consulted for Teva Neuroscience Canada. J.G., M.C., and J-L.S. were employees of Teva Neuroscience Canada. The study was funded by Teva Neuroscience Canada. H.S. and M.L. have no relevant disclosures.

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