A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients (NCT01964547) | Clinical Trial Compass
CompletedPhase 4
A Randomized Study of Sativex on Cognitive Function and Mood: Multiple Sclerosis Patients
Czechia121 participantsStarted 2012-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria (ALL to be fulfilled):
* Patient is willing and able to give informed consent for participation in the study.
* Patient is aged 18 years or above.
* Diagnosed with any disease sub-type of multiple sclerosis.
* Diagnosed with symptomatic spasticity due to multiple sclerosis.
* Patient has at least moderate spasticity in the opinion of the investigator.
* Patient fulfils at least one of the two criteria below. Subject must be either:
* Currently established on a regular dose of anti-spasticity therapy, or
* Previously tried and failed anti-spasticity therapy.
* Stable medication regimen for at least four weeks prior to study entry, for all medications which may have an effect on spasticity and/or cognition.
* If the patient is taking disease modifying medication this must be at a stable dose for three months prior to the initial visit.
* Willing and able to comply with all study requirements.
* Willing for his or her name to be notified to the responsible authorities for participation in this study, as applicable.
* Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria (if ANY apply):
* Any history or immediate family of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
* Any concomitant disease or disorder (such as poorly controlle…
What they're measuring
1
Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.