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1. Neuraxial analgesia is not associated with an increased risk of post-partum relapses in MS

Author

Lavie, Caroline, primary, Rollot, Fabien, additional, Durand-Dubief, Françoise, additional, Marignier, Romain, additional, Ionescu, Iuliana, additional, Casey, Romain, additional, Moreau, Thibault, additional, Tourniaire, Patricia, additional, Hutchinson, Michael, additional, D’Hooghe, Marie Béatrice, additional, Laplaud, David-Axel, additional, Clavelou, Pierre, additional, De Sèze, Jérôme, additional, Debouverie, Marc, additional, Brassat, David, additional, Pelletier, Jean, additional, Lebrun-Frenay, Christine, additional, Le Page, Emmanuelle, additional, Castelnovo, Giovanni, additional, Berger, Eric, additional, Hautecoeur, Patrick, additional, Heinzlef, Olivier, additional, Durelli, Luca, additional, Clerico, Marinella, additional, Trojano, Maria, additional, Patti, Francesco, additional, Vukusic, Sandra, additional, Alpérovitch, A., additional, Carton, H., additional, d’Hooghe, M.B., additional, Hommes, O., additional, Hutchinson, M., additional, Adeleine, P., additional, Biron, A., additional, Cortinovis-Tourniaire, P., additional, Grimaud, J., additional, Hours, M., additional, Moreau, T., additional, Vukusic, S., additional, Confavreux, C., additional, Chauplannaz, G., additional, Latombe, D., additional, Clanet, M., additional, Lau, G., additional, Rumbach, L., additional, Goas, J.Y., additional, Rouhart, F., additional, Mazingue, A., additional, Roullet, E., additional, Madigand, M., additional, Hautecoeur, P., additional, Brunet, P., additional, Edan, G., additional, Allaire, C., additional, Riffault, G., additional, Leche, J., additional, Benoit, T., additional, Simonin, C., additional, Ziegler, F., additional, Baron, J.C., additional, Rivrain, Y., additional, Dumas, R., additional, Loche, D., additional, Bourrin, J.C., additional, Huttin, B., additional, Delisse, B., additional, Gibert, I., additional, Boulay, C., additional, Verceletto, M., additional, Durand, G., additional, Bonneviot, G., additional, Gil, R., additional, Hedreville, M.A., additional, Belair, C., additional, Poitevin, R.J., additional, Devoize, J.L., additional, Wyremblewski, P., additional, Delestre, F., additional, Setiey, A., additional, Comi, G., additional, Filippi, M., additional, Ghezzi, A., additional, Martinelli, V., additional, Rossi, P., additional, Zaffaroni, M., additional, Tola, M.R., additional, Amato, M.P., additional, Fioretti, C., additional, Meucci, G., additional, Inglese, M., additional, Mancardi, G.L., additional, Gambi, D., additional, Thomas, A., additional, Cavazzuti, M., additional, Citterio, A., additional, Heltberg, A., additional, Hansen, H.J., additional, Fernandez, O., additional, Romero, F., additional, Arbizu, T., additional, Hernandez, J.J., additional, De Andres de Frutos, C., additional, Geffner Sclarky, D., additional, Aladro Benito, Y., additional, Reyes Yanes, P., additional, Aguilar, M, additional, Burguera, J.A., additional, Yaya, R., additional, Bonakim Dib, W., additional, Arzua-Mouronte, D., additional, Sindic, C.J.M., additional, Medaer, R., additional, Roose, H., additional, Geens, K.M.J., additional, Guillaume, D., additional, Van Zandycke, M., additional, Janssens, J., additional, Cornette, M., additional, Mol, L., additional, Weilbach, F., additional, Flachenecker, P., additional, Hartung, H.P., additional, Haas, J., additional, Tendolkar, I., additional, Sindrn, E., additional, Kölmel, H.W., additional, Reichel, D., additional, Rauch, M., additional, Preuss, S., additional, Poser, S., additional, Mauch, E., additional, Strausser-Fuchs, S., additional, Kolleger, H., additional, Hawkins, S., additional, Howell, S.J.L., additional, Rees, J.E., additional, Thompson, A., additional, Johnson, M., additional, Boggild, M., additional, Gregory, R.P., additional, Bates, D., additional, Bone, I., additional, Polman, C., additional, Frequin, S., additional, Jongen, P., additional, Correia de Sa, J., additional, Rio, M.E., additional, Huber, S., additional, Lechner-Scott, J., additional, Kappos, L., additional, Ionescu, I., additional, Cornu, C., additional, El-Etr, M., additional, Baulieu, E.E., additional, Schumacher, M, additional, Miller, D.H., additional, Pugeat, M., additional, d’Archangues, C., additional, Conard, J., additional, Ménard, J., additional, Sitruk-Ware, R., additional, Pelissier, C., additional, Dat, S., additional, Belaïsch-Allard, J., additional, Athéa, N., additional, Büschsenschutz, D., additional, Lyon-Caen, O., additional, Gonsette, R., additional, Boissel, J.P., additional, Ffrench, P., additional, Durand-Dubief, F., additional, Cotton, F., additional, Pachai, C., additional, Bracoud, L., additional, Androdias, G., additional, Marignier, R., additional, Laplaud, D.A., additional, Wiertlewski, S., additional, Lanctin-Garcia, C., additional, Couvreur, G., additional, Madinier, G., additional, Clavelou, P., additional, Taithe, F., additional, Aufauvre, D., additional, Guy, N., additional, Ferrier, A., additional, De Sèze, J., additional, Collongues, N., additional, Debouverie, M., additional, Viala, F., additional, Brassat, D., additional, Gerdelat-Mas, A., additional, Henry, P., additional, Pelletier, J., additional, Rico-Lamy, A., additional, Lebrun-Frenay, C., additional, Lepage, E., additional, Deburghraeve, V., additional, Castelnovo, G., additional, Berger, E., additional, Blondiau, M., additional, Heinzlef, O., additional, Coustans, M., additional, Clerc, C., additional, Rieu, L., additional, Lauxerois, M., additional, Hinzelin, G., additional, Ouallet, J.C., additional, Minier, D., additional, Vion, P., additional, Gromaire-Fayolle, N., additional, Derache, N., additional, Thouvenot, E., additional, Sallansonnet-Froment, M., additional, Tourniaire, P., additional, Toureille, L., additional, Borgel, F., additional, Stankoff, B., additional, Moroianu, C., additional, Guennoc, A.M., additional, Tournier-Gervason, C.L., additional, Peysson, S., additional, Trojano, M., additional, Patti, F., additional, D’Amico, E., additional, Motti, L., additional, Durelli, L., additional, and Tavella, A., additional

Published
2018
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2. The results of two multicenter, open-label studies assessing efficacy, tolerability and safety of protiramer, a high molecular weight synthetic copolymeric mixture, in patients with relapsing–remitting multiple sclerosis

Author

De Stefano, N, primary, Filippi, M, additional, Confavreux, C, additional, Vermersch, P, additional, Simu, M, additional, Sindic, C, additional, Hupperts, R, additional, Bajenaru, O, additional, Edan, G, additional, Grimaldi, L, additional, Marginean, I, additional, Medaer, R, additional, Orefice, G, additional, Pascu, I, additional, Pelletier, J, additional, Sanders, E, additional, Scarpini, E, additional, and Mancardi, GL, additional

Published
2008
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4. The results of two multicenter, open-label studies assessing efficacy, tolerability and safety of protiramer, a high molecular weight synthetic copolymeric mixture, in patients with relapsing–remitting multiple sclerosis

Author

Gilles Edan, E.A.C.M. Sanders, Giuseppe Orefice, Christian Sindic, Jean Pelletier, Elio Scarpini, I Marginean, Luigi M.E. Grimaldi, N. De Stefano, I Pascu, Christian Confavreux, Mihaela Simu, Massimo Filippi, Raymond Hupperts, Robert Medaer, Ovidiu Bajenaru, Patrick Vermersch, G. L. Mancardi, De Stefano, N, Filippi, Massimo, Confavreux, C, Vermersch, P, Simu, M, Sindic, C, Hupperts, R, Bajenaru, O, Edan, G, Grimaldi, L, Marginean, I, Medaer, R, Orefice, G, Pascu, I, Pelletier, J, Sanders, E, Scarpini, E, Mancardi, Gl, De Stefano, N., Filippi, M., Confavreux, C., Vermersch, P., Simu, M., Sindic, C., Hupperts, R., Bajenaru, O., Edan, G., Grimaldi, L., Marginean, I., Medaer, R., Orefice, Giuseppe, Pascu, I., Pelletier, J., Sanders, E., Scarpini, E., and Mancardi, G. L.

Subjects
Adult, Male, medicine.medical_specialty, Chemistry, Pharmaceutical, Injections, Subcutaneous, Pilot Projects, Relapsing-Remitting, multiple sclerosis, TV-5010, Gastroenterology, Injections, Dose-Response Relationship, Multiple Sclerosis, Relapsing-Remitting, Internal medicine, medicine, Clinical endpoint, Humans, Dosing, Glatiramer acetate, protiramer, Dose-Response Relationship, Drug, medicine.diagnostic_test, business.industry, Subcutaneous, Multiple sclerosis, Magnetic resonance imaging, Glatiramer Acetate, medicine.disease, drug therapy, Molecular Weight, Clinical trial, Chemistry, Dose–response relationship, Adult, Chemistry, Pharmaceutical, Dose-Response Relationship, Drug, Female, Humans, Immunosuppressive Agents, administration /&/ dosage/adverse effects/chemistry, Injections, Subcutaneous, Male, Molecular Weight, Multiple Sclerosis, drug therapy, Peptides, administration /&/ dosage/adverse effects/chemistry, Pilot Projects, Treatment Outcome, Treatment Outcome, Neurology, Tolerability, administration /&/ dosage/adverse effects/chemistry, Pharmaceutical, Female, glatiramer acetate, MRI, multiple sclerosis, protiramer, TV-5010, Neurology (clinical), Drug, Peptides, Nuclear medicine, business, Immunosuppressive Agents, MRI, medicine.drug
Abstract

Objective Two pilot studies were conducted to evaluate safety, tolerability, and efficacy of two doses of Protiramer (TV-5010) in patients with relapsing–remitting multiple sclerosis. Background Both glatiramer acetate and TV-5010 are synthetic copolymers comprised the same four amino acids in a defined molar ratio. TV-5010 has higher average molecular weight than Glatiramer acetate and might be hypothesized that glatiramoids with higher molecular weight might be more immunoreactive than lower molecular weight peptides, thus increasing therapeutic potential and allowing for less frequent dosing. Methods In the two separate studies, after a 10 week pretreatment period, TV-5010 was given subcutaneously once weekly at 15 mg and 30 mg for 36 weeks. The primary end point was a reduction in the number of magnetic resonance imaging active lesions (i.e., T1-weigthed gadolinium-enhancing and new T2-weighted lesions) between the pretreatment period and the end of study. Results Both TV-5010 doses were generally well tolerated. The treatment with TV-5010 at a dose of 15 mg/wk did not show any significant effect. In contrast, in patients treated with at a dose of 30 mg/wk, a significant reduction in the mean number of gadolinium-enhancing (−58.8%; P = 0.0013) and new T2-W (−50%; P = 0.0002) lesions was observed. However, a large decrease in the mean number of both gadolinium-enhancing (−55%) and new T2-W (−40%) lesions during the pretreatment period made difficult the interpretation of the efficacy assessments. Conclusions Further studies are needed to confirm these preliminary data on safety and efficacy of TV-5010 at a weekly dose of 30 mg.

Published
2008
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5. Boosting endogenous neuroprotection in multiple sclerosis: the ASsociation of Inosine and Interferon beta in relapsing- remitting Multiple Sclerosis (ASIIMS) trial.

Author

Gonsette RE, Sindic C, D'hooghe MB, De Deyn PP, Medaer R, Michotte A, Seeldrayers P, and Guillaume D

Subjects
Adult, Anti-Inflammatory Agents adverse effects, Belgium, Disability Evaluation, Disease Progression, Double-Blind Method, Drug Therapy, Combination, Female, Humans, Inosine adverse effects, Inosine metabolism, Interferon beta-1a, Interferon beta-1b, Interferon-beta adverse effects, Kaplan-Meier Estimate, Male, Middle Aged, Multiple Sclerosis, Relapsing-Remitting blood, Multiple Sclerosis, Relapsing-Remitting diagnosis, Neuroprotective Agents adverse effects, Neuroprotective Agents metabolism, Severity of Illness Index, Time Factors, Treatment Outcome, Uric Acid blood, Anti-Inflammatory Agents therapeutic use, Inosine therapeutic use, Interferon-beta therapeutic use, Multiple Sclerosis, Relapsing-Remitting drug therapy, Neuroprotective Agents therapeutic use
Abstract

Anti-inflammatory drugs are effective on relapses, but neuroprotective agents to prevent disability are still unavailable. Uric acid has neuroprotective effects in experimental models including encephalomyelitis and appears to be involved in multiple sclerosis. Oral administration of inosine, a precursor of uric acid, increases serum uric acid levels and is well tolerated. Our objective was to test the possibility that a combination therapy associating an anti-inflammatory drug (interferon beta) and an endogenous neuroprotective molecule (uric acid) would be more effective than interferon beta alone on the accumulation of disability. Patients with relapsing-remitting multiple sclerosis on interferon beta for at least 6 months were randomized to interferon beta + inosine or interferon beta + placebo for 2 years. The dose of inosine was adjusted to maintain serum uric acid levels in the range of asymptomatic hyperuricaemia (

Published
2010
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6. The results of two multicenter, open-label studies assessing efficacy, tolerability and safety of protiramer, a high molecular weight synthetic copolymeric mixture, in patients with relapsing-remitting multiple sclerosis.

Author

De Stefano N, Filippi M, Confavreux C, Vermersch P, Simu M, Sindic C, Hupperts R, Bajenaru O, Edan G, Grimaldi L, Marginean I, Medaer R, Orefice G, Pascu I, Pelletier J, Sanders E, Scarpini E, and Mancardi GL

Subjects
Adult, Chemistry, Pharmaceutical, Dose-Response Relationship, Drug, Female, Glatiramer Acetate, Humans, Immunosuppressive Agents adverse effects, Immunosuppressive Agents chemistry, Injections, Subcutaneous, Male, Molecular Weight, Peptides adverse effects, Peptides chemistry, Pilot Projects, Treatment Outcome, Immunosuppressive Agents administration & dosage, Multiple Sclerosis, Relapsing-Remitting drug therapy, Peptides administration & dosage
Abstract

Objective: Two pilot studies were conducted to evaluate safety, tolerability, and efficacy of two doses of Protiramer (TV-5010) in patients with relapsing-remitting multiple sclerosis., Background: Both glatiramer acetate and TV-5010 are synthetic copolymers comprised the same four amino acids in a defined molar ratio. TV-5010 has higher average molecular weight than Glatiramer acetate and might be hypothesized that glatiramoids with higher molecular weight might be more immunoreactive than lower molecular weight peptides, thus increasing therapeutic potential and allowing for less frequent dosing., Methods: In the two separate studies, after a 10 week pretreatment period, TV-5010 was given subcutaneously once weekly at 15 mg and 30 mg for 36 weeks. The primary end point was a reduction in the number of magnetic resonance imaging active lesions (i.e., T1-weigthed gadolinium-enhancing and new T2-weighted lesions) between the pretreatment period and the end of study., Results: Both TV-5010 doses were generally well tolerated. The treatment with TV-5010 at a dose of 15 mg/wk did not show any significant effect. In contrast, in patients treated with at a dose of 30 mg/wk, a significant reduction in the mean number of gadolinium-enhancing (-58.8%; P = 0.0013) and new T2-W (-50%; P = 0.0002) lesions was observed. However, a large decrease in the mean number of both gadolinium-enhancing (-55%) and new T2-W (-40%) lesions during the pretreatment period made difficult the interpretation of the efficacy assessments., Conclusions: Further studies are needed to confirm these preliminary data on safety and efficacy of TV-5010 at a weekly dose of 30 mg.

Published
2009
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