Spasticity due to multiple sclerosis identified as "responders" and "not responders" under treatment with Sativex MedDRA version: 14.1 Level: LLT Classification code 10041416 Term: Spasticity System Organ Class: 100000004852
Conditions
Interventions
Trade Name: SATIVEX
Product Name: sativex
Product Code: N02BG10
Pharmaceutical Form: Oromucosal solution
INN or Proposed INN: pending
CAS Number: 13956-29-1
Current Sponsor code: pending
Other descrip
Sponsors
JOSE MANUEL GARCIA DOMINGUEZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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. Pregnancy 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether EMG (H,W waves and withdraw reflex) is useful for the characterization of spasticity;Secondary Objective: To assess if sativex is able to modify spasticity when using objective measures. To assess mood and behavioural changes induced by Sativex.;Primary end point(s): H/M, F/M ratio and withdraw reflex slope variations;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Date of birth Gender Date of diagnosis MS subtype MS treatment Disability as measured by EDSS Treatment for spasticity Ashworth scale Numeric Rating Scale 25-feet walk test Symbol DigitModalities Test Modified Fatigue ImpactScale MFIS Hamilton depression score MultipleSclerosisQuality of Life-54 (MSQoL-54;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Countries
Spain
Contacts
Public ContactJose Manuel García
José Manuel García
Outcome results
None listed