INTERVENTIONALCOMPLETEDNCT01538225

Neurophysiologic Study on Effects of Sativex® on Spasticity in Progressive Multiple Sclerosis

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).

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2014-01-20

What this record can show

Protocol only - no registry results posted

This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 45 (ACTUAL)
Start date: 2012-04
Sponsor: Almirall, S.A.
Design: RANDOMIZED · CROSSOVER · TREATMENT
Locations: 1
Results record: Not present in registry snapshot

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Multiple Sclerosis

Cannabinoids and active compounds

No governed compound link was found.

Medicines

SATIVEX

Interventions

What was registered

DRUG

Sativex®

THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients. Duration: 2 weeks

DRUG

Placebo

Placebo Same frequency and dosage form as Sativex. Duration: 2 weeks

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

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

primary measures

H/M reflex ratio

Time frame: week 0, 4

To evaluate differences in the H/M ratio scores within subjects affected by progressive MS at baseline and week 4.

secondary outcomes

secondary measures

Neurophysiology ·H/M ratio ·Transcranial Magnetic Stimulation a) MEP Motor threshold, upper limb b) MEPs amplitudes c) Intracortical facilitation/inhibition (ICI/ICF), upper limb

Time frame: week 0, 4, 6 and 10

Neurophysiology * 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 1. Motor threshold to obtain MEPs to the upper limb (time 0-4; 6-10 weeks); 2. 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 compound muscle potential in response to peripheral stimulation (time 0-4; 6-10 weeks); 3. Intracortical facilitation/inhibition (ICI/ICF) to the upper limb (time 0-4; 6-10 weeks);

Adverse Events recording

Time frame: week 0, 4, 6 and 10

Spasticity: ·0-10 11-point numerical spasticity rating scale (NRS) ·Mean modified Ashworth scale (MAS)

Time frame: week 0, 4, 6, 10

Mean spasticity score recorded using a 0-10 11-point numerical spasticity rating scale (NRS) at baseline (pre-treatment) and week 4, 6 and 10 · Mean modified Ashworth (MAS) score at baseline (pre-treatment), week 4, 6, 10

Function: ·Timed 25 feet and 10 meters walk ·Hand dexterity measured with 9-HPT

Time frame: week 0, 4, 6, 10

Function: * Mean Timed 25 feet and 10 meters walk recorded at baseline (pre-treatment) and week 4, 6, 10 * Mean Hand dexterity measured with 9-HPT recorded at baseline (pre-treatment) and week 4, 6, 10

Other MS Symptoms: ·Sleep Quality NRS ·Pain NRS and Spasm frequency ·Fatigue Severity Scale (FSS)

Time frame: week 0, 4, 6, 10

Other MS Symptoms: * Mean Sleep Quality NRS recorded at baseline (pre-treatment) and week 4, 6, 10 * Pain NRS and Spasm frequency recorded at baseline (pre-treatment) and week 4, 6, 10 * Fatigue measured with the Fatigue Severity Scale (FSS) recorded at baseline (pre-treatment) and week 4, 6, 10

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: 896d4568-e03d-4931-a2e9-521fadeca345
Retrieved: 11/09/2026, 14:16:28
SHA-256: 5634ecc93c83f79ce615ef2c7d8c1a6fdc70c556e1a4765afcf3450aa6e8e83d