Overall, we endorse their suggestions, especially the usefulness of a delayed start design and the need for open-label phases in which all patients would receive the active drug for longer periods after a positive shortduration randomised trial. Because of regulatory and economic hurdles, open-label phases were difficult to plan in our populations of patients: only three patients remained on riluzole therapy from the first trial3 (one died from multisystem atrophy, but two patients are doing well, without adverse effects or progression, after 5 years of follow-up).
Riluzole in patients with hereditary cerebellar ataxia. Authors' reply / Romano, Silvia; Coarelli, Giulia; Vanacore, Nicola; Salvetti, Marco; Ristori, Giovanni. - In: LANCET NEUROLOGY. - ISSN 1474-4422. - 15:8(2016), pp. 789-789. [10.1016/S1474-4422(16)00117-4]
Riluzole in patients with hereditary cerebellar ataxia. Authors' reply
ROMANO, SILVIA;COARELLI, GIULIA;VANACORE, NICOLA;SALVETTI, Marco;RISTORI, GIOVANNI
2016
Abstract
Overall, we endorse their suggestions, especially the usefulness of a delayed start design and the need for open-label phases in which all patients would receive the active drug for longer periods after a positive shortduration randomised trial. Because of regulatory and economic hurdles, open-label phases were difficult to plan in our populations of patients: only three patients remained on riluzole therapy from the first trial3 (one died from multisystem atrophy, but two patients are doing well, without adverse effects or progression, after 5 years of follow-up).File | Dimensione | Formato | |
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