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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline to the End of Treatment in Paced Auditory Serial Addition Test (PASAT) Total Score.