Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Almirall, S.A.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 least 12 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 modified 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
You may not be if
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
Clareo Health | Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity
