Clinical trial NCT01538225: Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity
Official title: Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Spasticity
Lead sponsor: Almirall, S.A.
Sponsor class: INDUSTRY
First posted: 2012-02-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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).


Eligibility 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

Primary outcomes:
measure: H/M reflex ratio
timeFrame: week 0, 4
Secondary outcomes:
measure: Neurophysiology ·H/M ratio ·Transcranial Magnetic Stimulation a) MEP Motor threshold, upper limb b) MEPs amplitudes c) Intracortical facilitation/inhibition (ICI/ICF), upper limb
timeFrame: week 0, 4, 6 and 10
measure: Adverse Events recording
timeFrame: week 0, 4, 6 and 10
measure: Spasticity: ·0-10 11-point numerical spasticity rating scale (NRS) ·Mean modified Ashworth scale (MAS)
timeFrame: week 0, 4, 6, 10
measure: Function: ·Timed 25 feet and 10 meters walk ·Hand dexterity measured with 9-HPT
timeFrame: week 0, 4, 6, 10
measure: Other MS Symptoms: ·Sleep Quality NRS ·Pain NRS and Spasm frequency ·Fatigue Severity Scale (FSS)
timeFrame: week 0, 4, 6, 10
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Institute of Experimental Neurology
Study officials:
affiliation: Institute of Experimental Neurology (Milan, Italy)
name: Giancarlo Comi, Prof
role: PRINCIPAL_INVESTIGATOR
References: