Study on the Use of surface electromyography in the detection of objective differencies in patients with spasticity due to multiple sclerosis identified as responders and not responders under treatment with Sativex

JOSE MANUEL GARCIA DOMINGUEZ0 个研究点开始时间: 2012年1月25日最近更新: 2014年6月2日

适应症

试验速览

暂无简介。

•Both sex subjects older than 18.
•Diagnosis of Multiple Sclerosis according to current McDonald criteria, with moderate to severe spasticity
•Patients under prescription of Sativex according to the current approved indications by EMA/AEMPS, initiating treatment in the moment of inclusion. Decision of treatment should be previous and independent of study participation.
•Women in reproductive age must have a negative serum/urine pregnancy test at selection visit, and accept to take contraceptive measures from at least 14 days prior to the first dose of the drug and at least 3 months after the last dose.
•Patients giving written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 29
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Relapse 30 days prior to inclusion
•Methylprednisolone administration (orally or intranvenous) 30 days prior to inclusion.
•Botullinum toxin administration for spasticity in the 4 months prior to inclusion.
•Contraindication for Sativex as to current indication uses.
•Hypersensitivity to Cannabinoids or any excipient.
•Personal history, known or suspected, or with familiar history of schizophrenia or other psycotic conditions, personal history of serious personality disorder or other important psychiatric conditions, apart from depression due to underlying disease.
•Breastfeeding

发起方

JOSE MANUEL GARCIA DOMINGUEZ