Overview

Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

Status:
Completed
Trial end date:
2013-11-01
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
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