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Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity

NCT01538225 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-01-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Giancarlo Comi, Prof · Institute of Experimental Neurology (Milan, Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01538225 on ClinicalTrials.gov