Neurophysiological Study of Sativex in Multiple Sclerosis (MS) Spasticity (NS-MSS)

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Almirall

Status and phase

Completed
Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Sativex®
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01538225
2011-002258-30 (EudraCT Number)
M/SATIVX/01

Details and patient eligibility

About

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).

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

45 participants in 2 patient groups

first sativex, second placebo
Experimental group
Description:
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)
Treatment:
Drug: Placebo
Drug: Sativex®
first placebo, second sativex
Experimental group
Description:
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)
Treatment:
Drug: Placebo
Drug: Sativex®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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