CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 121 enrolled
Drug / intervention
Sativex +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01964547
NCT01964547Phase 4Completed
CompareCT.gov

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

Jazz Pharmaceuticals·interventional·Posted Oct 17, 2013·Updated Jan 12, 2023

In Brief

A Phase 4 clinical trial evaluating Sativex and Placebo for Multiple Sclerosis and Spasticity. Completed, enrolled 121 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Spasticity
CountriesCzechia
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2013
Enrollment StartJan 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.7 years ago

Interventions

Sativexdrug

Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).

Placebodrug

Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).