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Completed

NCT Number: NCT01538225

Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institute of Experimental Neurology

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sativex®

Drug

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

Placebo

Drug

Placebo

Same frequency and dosage form as Sativex.

Duration: 2 weeks

Primary outcomes

  1. 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

  1. 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
    • 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 compound muscle potential in response to peripheral stimulation (time 0-4; 6-10 weeks);
    • Intracortical facilitation/inhibition (ICI/ICF) to the upper limb (time 0-4; 6-10 weeks);

  2. Adverse Events recording

    Time frame: week 0, 4, 6 and 10

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Registry information

Official study title

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

Acronym: NS-MSS

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 24, 2012
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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