CLINICAL STUDY TO EVALUATE THE EFFECTIVENESS OF Sativex in relieving pain PEOPLE AFFECTED BY MULTIPLE SCLEROSIS

Conditions: Subject of both male and female gender affected by Secondary-Progressive (SP) or Primary-Progressive (PP) MS
MedDRA version: 14.1Level: SOCClassification code 10029205Term: Nervous system disordersSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-002258-30-IT

Lead Sponsor: ALMIRALL PRODESFARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Aged 18 years or above Willing and able to comply with the protocol for the duration of the study Diagnosis of Secondary-Progressive or Primary-Progressive MS from at least12 months Relapse free from at least 3 months before screening visit Lower limb spasticity EDSS from >3.0 and < 6.5 Moderate to severe spasticity due to MS from at least 6 months and with stable drug treatment not able to relieve symptoms as a whole, deserving a specific add-on treatment Immunomodulatory or immunosuppressant therapies not modifed during the study and 6 months before starting the study Stable doses of anti-spasticity agents from at least 2 months prior to screening visit Have given written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

Any concomitant disease that may cause spasticity or that could interfere with subject’s spasticity Botulinum Toxin injection for spasticity in the 4 months prior to screening visit Any known or suspected history of psychotic illness, alcohol or substance abuse, epilepsy, hypersensitivity to cannabinoids Significant cardiac, renal or hepatic disease Female subjects of child bearing potentials and male subjects whose partner is child bearing potential, unless willing to ensure that they or their partner use contraception during the study Female subjects who is pregnant lactating or planning pregnancy during the course of the study and for three months thereafter Sativex SmPC contraindications