NS-MSS
What it found
We found no results in the registry or in papers.
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Nabiximols
- Cannabidiol
Cannabinoid CB1 receptor negative allosteric modulator
Placebo or sham
- Placebo
What it measured
Main measures
H/M reflex ratio
week 0, 4
• To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.
Other measures (6)
Neurophysiology ·H/M ratio ·Transcranial Magnetic Stimulation a) MEP Motor threshold, upper limb b) MEPs amplitudes c) Intracortical facilitation/inhibition (ICI/ICF), upper limb
week 0, 4, 6 and 10
Arm and hand functionNerve conduction testsAdverse Events recording
week 0, 4, 6 and 10
SafetySpasticity: ·0-10 11-point numerical spasticity rating scale (NRS) ·Mean modified Ashworth scale (MAS)
week 0, 4, 6, 10
SpasticityFunction: ·Timed 25 feet and 10 meters walk ·Hand dexterity measured with 9-HPT
week 0, 4, 6, 10
Disability progressionWalking and mobilityArm and hand functionOther MS Symptoms: ·Sleep Quality NRS ·Pain NRS and Spasm frequency ·Fatigue Severity Scale (FSS)
week 0, 4, 6, 10
FatigueSpasticityPainMood and sleepNeurophysiology H/M ratio: To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at weeks 6 and 10 Transcranial Magnetic Stimulation Motor threshold to obtain MEPs to the upper limb (time 0-4; 6-10 weeks); MEPs amplitudes at 15% above motor threshold, measured as MEP/M ratio to APB (abductor pollicis brevis) and abductor of hallucis, in which M is the
Disability progressionFatigueWalking and mobilityArm and hand functionNerve conduction testsSpasticityPainMood and sleep
Who could take part
Progressive MS · 18 and over
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
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History
Started
Apr 2012
Main results due
Nov 2013
Finished
Nov 2013
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