NCT01964547

A Multicentre, Double-blind, Randomised, Parallel Group, Placebo-controlled Study of the Effect of Long-term Treatment With Sativex on Cognitive Function and Mood of Patients With Spasticity Due to Multiple Sclerosis

Completed Phase 4 Results posted Last updated 19 December 2022

What this trial tests

Phase 4 trial testing Sativex in Multiple Sclerosis in 121 participants. Completed in 1 May 2013.

Timeline

1 January 2012

Primary endpoint
1 May 2013

1 May 2013

Quick facts

Lead sponsor	Jazz Pharmaceuticals
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	121
Start date	1 January 2012
Primary completion	1 May 2013
Estimated completion	1 May 2013
Sites	1 location across Czechia

Drugs / interventions tested

• Sativex — full drug profile →
• Placebo

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →
• Spasticity — all drugs for Spasticity →

Sponsor

Jazz Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Multiple Sclerosis or Spasticity. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.
  Time frame: 0-48 weeks
  The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. Stimulus presentation rates were adapted for use with multiple sclerosis patients. The PASAT is presented on audio compact disk to control the rate of stimulus presentation. Single digits are presented either every 3 seconds (PASAT 1) or eve

Sponsor's own description

A study to compare the change in cognitive performance and psychological status of patients with spasticity due to Multiple Sclerosis when treated with Sativex or placebo, added to existing anti-spasticity therapy over a period of 48 weeks. Secondary objectives were to evaluate the effect of Sativex on mood and spasticity and to assess the safety and tolerability of Sativex.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. G protein-coupled receptors in neurodegenerative diseases and psychiatric disorders.
   Wong TS, Li G, Li S, Gao W, et al · · 2023 · cited 113× · PMID 37137892 · DOI 10.1038/s41392-023-01427-2
2. Cannabinoids for the treatment of dementia.
   Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, et al · · 2021 · cited 28× · PMID 34532852 · DOI 10.1002/14651858.cd012820.pub2