Overview
Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity
Status:
Completed
Completed
Trial end date:
2013-11-01
2013-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Aim of this randomized, double-blind, placebo-controlled, cross-over study is to investigate cannabinoid-induced changes in neurophysiological parameters in a group of 40 patients with secondary or primary progressive Multiple Sclerosis (MS).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Almirall, S.A.Treatments:
Nabiximols
Criteria
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 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
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