Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

NCT01538225 | Completed Phase 3 DMC

• 2 other identifiers: M/SATIVX/012011-002258-30
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Sclerosis

Keywords

Spasticity

Outcome Measures

Primary Outcomes (1)

• H/M reflex ratio

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

  week 0, 4

Secondary Outcomes (5)

• 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

• Adverse Events recording

  week 0, 4, 6 and 10

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

  week 0, 4, 6, 10

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

  week 0, 4, 6, 10

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

  week 0, 4, 6, 10

Study Arms (2)

first sativex, second placebo

EXPERIMENTAL

2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (Sativex), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (placebo)

Drug: Sativex®; Drug: Placebo

first placebo, second sativex

EXPERIMENTAL

2 weeks first titration period (as per approved SmPC), a 2-week first treatment period (placebo), a 2-week washout, a cross-over followed by another 2 weeks titration period (as per SmPC), followed by a second 2-week period treatment (Sativex)

Drug: Sativex®; Drug: Placebo

Interventions

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

first placebo, second sativex; first sativex, second placebo

Placebo DRUG

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

first placebo, second sativex; first sativex, second placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Almirall, S.A.: lead

Study Sites (1)

Institute of Experimental Neurology

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Study Officials

• Giancarlo Comi, Prof

  Institute of Experimental Neurology (Milan, Italy)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2012
• First Posted: February 24, 2012
• Study Start: April 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: January 20, 2014

Record last verified: 2014-01

Locations

IT (1)